https://github.com/advisoryops/advisoryopsHealthcare and medical device cybersecurity advisoriesTue, 27 Oct 2026 12:11:05 +0000en-ushttps://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0032-2014"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0032-2014"The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0. | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. | Bio-Rad Laboratories | Class Class IIIP0https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0070-2021"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0070-2021"It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01. | Neoprobe GDS Control Unit, Model Number NPCU3 | Devicor Medical Products Inc | Class Class IIIP0https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36309https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36309Wed, 15 Dec 2004 00:00:00 +0000Historical FDA recall Z-0341-05 for Philips HeartStart MRx monitor/defibrillator models M3535A and M3536A. The recall concerns a possible delay in energy delivery when the sync function is enabled and the device switches from manual to AED mode. FDA lists software versions A.02.00 and lower in the code information. Philips notified customers by letter in December 2004, with interim risk mitigation pending correction by a company representative. The recall was initiated on 2004-12-15 and terminatP0https://api.fda.gov/device/recall.json?search=res_event_number:"31955"https://api.fda.gov/device/recall.json?search=res_event_number:"31955"Tue, 14 Sep 2010 00:00:00 +0000The device may disarm and not deliver shock when performing a Synchronized Cardioversion | Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A | Philips Medical Systems | Device: Automated External Defibrillators (Non-Wearable).P0https://api.fda.gov/device/recall.json?search=res_event_number:"30915"https://api.fda.gov/device/recall.json?search=res_event_number:"30915"Sat, 06 May 2006 00:00:00 +0000The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so. | LIFEPAK 12 defibrillator/ monitors biphasic | Medtronic Emergency Response Systems, Inc. | Device: Automated External Defibrillators (Non-Wearable).P0https://api.fda.gov/device/recall.json?search=res_event_number:"34685"https://api.fda.gov/device/recall.json?search=res_event_number:"34685"Sun, 25 Jun 2006 00:00:00 +0000Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge. | Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982. | Cardiac Science Corporation | Device: Automated External Defibrillators (Non-Wearable).P0https://api.fda.gov/device/recall.json?search=res_event_number:"31212"https://api.fda.gov/device/recall.json?search=res_event_number:"31212"Wed, 08 Jun 2011 00:00:00 +0000The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition. | Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected). | Heartsine Technologies Inc | Device: Automated External Defibrillators (Non-WearablP0https://api.fda.gov/device/recall.json?search=res_event_number:"25286"https://api.fda.gov/device/recall.json?search=res_event_number:"25286"Tue, 27 May 2003 00:00:00 +0000Adverse events- suspected pseudoaneurysm | Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. | Cook Biotech, Inc. | Device: Implantable Pacemaker Pulse-Generator.P0https://api.fda.gov/device/recall.json?search=res_event_number:"27418"https://api.fda.gov/device/recall.json?search=res_event_number:"27418"Thu, 17 Feb 2005 00:00:00 +0000Potential for early depletion of Implantable Cardioverter Defibrillator battery. | Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. | Biotronik Inc | Device: Implantable Cardioverter Defibrillator (Non-Crt).P0https://api.fda.gov/device/recall.json?search=res_event_number:"32465"https://api.fda.gov/device/recall.json?search=res_event_number:"32465"Mon, 26 Mar 2012 00:00:00 +0000The vendor has released a non-invasive firmware update for several models of Implantable Cardioverter Defibrillators to address issues related to Skipped-Charge Shock and Sensor Noise Anomaly. It is important to ensure that these devices are updated promptly to maintain their proper functionality. Please check if your devices are affected and proceed with the upgrade as soon as possible. | Device: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D). | ImplanP0https://www.cisa.gov/news-events/ics-medical-advisories/icsma-26-041-01https://www.cisa.gov/news-events/ics-medical-advisories/icsma-26-041-01The ZOLL ePCR IOS application has a critical vulnerability that allows attackers to read sensitive local files, potentially exposing patient data and device information. A patch is not mentioned, so immediate action is required. We recommend ensuring that this application is monitored closely and access is limited until more information about the vulnerability is provided.P1https://www.cisa.gov/news-events/ics-medical-advisories/icsma-25-198-01https://www.cisa.gov/news-events/ics-medical-advisories/icsma-25-198-01Panoramic Corporation's Digital Imaging Software version 9.1.2.7600 has a critical vulnerability that allows local attackers to gain higher access privileges. A patch is not mentioned, so immediate action is advised. It is recommended to restrict access to this software until further updates are provided.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2021/icsma-21-313-01.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2021/icsma-21-313-01.jsonPhilips MRI 1.5T and MRI 3T Version 5.3 through 5.8.1 does not restrict or incorrectly restricts access to a resource from an unauthorized actor.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2021/icsma-21-313-01.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2021/icsma-21-313-01.jsonPhilips MRI 1.5T and MRI 3T Version 5.3 through 5.8.1 does not restrict or incorrectly restricts access to a resource from an unauthorized actor.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2021/icsma-21-313-01.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2021/icsma-21-313-01.jsonPhilips MRI 1.5T and MRI 3T Version 5.3 through 5.8.1 does not restrict or incorrectly restricts access to a resource from an unauthorized actor.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-218-01.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-218-01.jsonThu, 06 Aug 2026 00:00:00 +0000Opening a crafted DICOM file containing malicious JPEG-compressed pixel data triggers an attacker-controlled heap out-of-bounds write, which may allow an attacker to remotely execute arbitrary code.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonThu, 15 Oct 2026 00:00:00 +0000Successful exploitation of these vulnerabilities could allow an attacker to delete stored medical images, disclose patient information, inject forged studies, reassign patient records, overwrite files, and cause a denial-of-service condition.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonThu, 15 Oct 2026 00:00:00 +0000Successful exploitation of these vulnerabilities could allow an attacker to delete stored medical images, disclose patient information, inject forged studies, reassign patient records, overwrite files, and cause a denial-of-service condition.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonThu, 15 Oct 2026 00:00:00 +0000Successful exploitation of these vulnerabilities could allow an attacker to delete stored medical images, disclose patient information, inject forged studies, reassign patient records, overwrite files, and cause a denial-of-service condition.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonThu, 15 Oct 2026 00:00:00 +0000Successful exploitation of these vulnerabilities could allow an attacker to delete stored medical images, disclose patient information, inject forged studies, reassign patient records, overwrite files, and cause a denial-of-service condition.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonThu, 15 Oct 2026 00:00:00 +0000Successful exploitation of these vulnerabilities could allow an attacker to delete stored medical images, disclose patient information, inject forged studies, reassign patient records, overwrite files, and cause a denial-of-service condition.P1https://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonhttps://raw.githubusercontent.com/cisagov/CSAF/develop/csaf_files/OT/white/2026/icsma-26-288-02.jsonThu, 15 Oct 2026 00:00:00 +0000Successful exploitation of these vulnerabilities could allow an attacker to delete stored medical images, disclose patient information, inject forged studies, reassign patient records, overwrite files, and cause a denial-of-service condition.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0017-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0017-2016"If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | Toshiba Aquilion CT System TSX-302A | Toshiba American Medical Systems Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0068-2015"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0068-2015"Merge Healthcare's eFilm Workstation versions 4.0 and 4.0.1 have a medium-severity issue that can result in selecting the wrong medical study when multiple studies are open. While there is no patch available for this issue, it is important for staff to be cautious when using the thumbnail panel for study selection. Consider limiting the number of studies open at once to minimize errors.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0052-2014"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0052-2014"A software issue in the Siemens Acuson SC2000 ultrasound system may lead to inaccurate 3D images, potentially causing ablation in the wrong location. No patch is available at this time, so it is important to monitor the situation closely. Ensure that staff is aware of this issue and double-check images prior to any procedures.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0035-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0035-2018"St. Jude Medical has released new firmware for their implantable pacemakers to reduce the risk of unauthorized access via radio frequency communications. This is important for enhancing the security of devices such as the PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST. Please ensure that these devices are updated with the latest firmware as recommended to maintain operational security.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0020-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0020-2025"Philips North America has identified a configuration issue in their IntelliVue Patient Monitors MX400, MX450, MX500, and MX550, which may prevent enhanced arrhythmia alarms from functioning. This issue affects devices with a specific software version (P.01.01) and Option CP2. It's recommended to verify device configurations and reach out to Philips for guidance on remediation.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0009-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0009-2025"Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy. | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample PreP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0117-2020"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0117-2020"Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters. | Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-00P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0096-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0096-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0110-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0110-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0017-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0017-2018"During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. | Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectionP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0030-2026"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0030-2026"Due to software issue, radiology reports may not be fully displayed when viewing. | Change Healthcare Radiology Solutions software version 14.2.2 | CHANGE HEALTHCARE CANADA COMPANY | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0078-2015"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0078-2015"Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden). | VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, sP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0079-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0079-2018"The devices have an incorrect firmware configuration. | VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0034-2014"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0034-2014"GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List, or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies wityh a label (Curr | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACSP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0106-2017"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0106-2017"Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. | cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0107-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0107-2016"Software and firmware bugs | SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients. | Siemens Medical Solutions USA, Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0036-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0036-2018"St. Jude Medical has released new firmware for their pacemakers to improve security against unauthorized access via radio frequency communications. This update is important for models PM 1250, PM 2250, PM1282, and PM2282. Hospital staff should ensure these devices are updated promptly to maintain patient safety.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0105-2015"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0105-2015"Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped | Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements. | Philips Medical Systems, Inc. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0056-2013"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0056-2013"The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used. | AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0115-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0115-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0096-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0096-2019"GE Healthcare's CARESCAPE Monitor B850 may reset if there is a prolonged network overload while multiple units are connected to the same network. Currently, there is no patch available for this issue. It's recommended to monitor network performance and ensure it can handle the load to avoid potential monitor disruptions.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0112-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0112-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0099-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0099-2018"Observed instability of the device. | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instrumenP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0116-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0116-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2018"During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. | Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectionaP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0020-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0020-2018"During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. | Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-secP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0119-2023"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0119-2023"Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system. | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens Medical Solutions USA, Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0069-2021"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0069-2021"During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system. | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC). | Nuvasive Specialized Orthopedics Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0116-2020"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0116-2020"Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters. | Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0040-2026"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0040-2026"Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. | EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202 | CORNEAT VISION, LTD. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0030-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0030-2018"St. Jude Medical has released new firmware for certain pacemaker models to improve security against unauthorized access via radio frequency communications. The severity of the issue has been assessed as high, and a patch is available. Health IT staff should ensure the firmware is updated on affected devices to protect patient safety.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0066-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0066-2019"Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI. | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0063-2015"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0063-2015"Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System. | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissectP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0010-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0010-2019"The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blooP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0039-2026"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0039-2026"Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. | CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m | CORNEAT VISION, LTD. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0070-2017"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0070-2017"O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images | Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0112-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0112-2019"GE Healthcare's MRI Systems may have an issue where images can be flipped or patient data could mismatch if the latest software version wasn't reinstalled after service activities. This is considered a medium severity issue, and while there is no patch available, it's crucial to verify that the correct software version is installed at your facilities. Take immediate steps to ensure all affected devices are reviewed and updated as necessary to prevent potential errors.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0013-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0013-2016"If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | Toshiba Aquilion CT System TSX-101A | Toshiba American Medical Systems Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0111-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0111-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0094-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0094-2018"The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered. | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planarP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0008-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0008-2018"FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0025-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0025-2025"When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians. | Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnoP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0113-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0113-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0038-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0038-2018"St. Jude Medical has released new firmware for their QUADRA RELIEVE and QUADRA ALLURE MP pacemakers to reduce the risk of unauthorized access via radio frequency communications. This issue is classified as Medium severity, and a patch is now available. It is recommended to update the firmware on these devices as soon as possible to enhance security.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0106-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0106-2016"This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes. | Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and rP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0096-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0096-2018"Possible break in the connector of the Force Sensor. | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosuP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0099-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0099-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0095-2024"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0095-2024"Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0021-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0021-2016"software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin | SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0037-2026"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0037-2026"It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area parP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0133-2022"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0133-2022"Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. | SIGNA Architect nuclear magnetic resonance imaging system | GE Healthcare, LLC | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2026"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2026"Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. | Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | Getinge Disinfection Ab | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0112-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0112-2016"Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. | Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0014-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0014-2016"If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | Toshiba Aquilion CT System TSX-301A | Toshiba American Medical Systems Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0118-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0118-2019"Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system | AS-OBGYN Information System version 7.824.x | AS Software, Inc. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0115-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0115-2018"Potential for software to change the final tool orientation for the command position without command. | ROSA Surgical Device 2.5.8 | Zimmer Biomet, Inc. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2016"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2016"If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | Toshiba Aquilion CT System TSX-301C | Toshiba American Medical Systems Inc | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0104-2017"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0104-2017"Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. | RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0111-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0111-2019"There is a risk of incorrect image display and patient data mismatches in GE Healthcare MRI Systems, specifically those running Software Version 12.x. This vulnerability has been rated as High severity, but no patch is currently available. It is recommended to verify that the software has been correctly reinstalled after any service to avoid these issues.P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0084-2022"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0084-2022"Under certain conditions, there is a risk for a false negative result. | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System | BioMerieux SA | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0079-2024"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0079-2024"A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0101-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0101-2025"Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2014"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0016-2014"Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10DP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0077-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0077-2018"The devices have an incorrect firmware configuration. | RESONATE EL ICD VR, Model D432, Sterile. | Boston Scientific Corporation | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0122-2024"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0122-2024"When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data. | Functional MR V1.0 | OLEA MEDICAL | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0107-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0107-2019"If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion. | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 | Baxter Healthcare Corporation | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0109-2022"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0109-2022"Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds | Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400 | Draeger Medical, Inc. | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0068-2026"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0068-2026"Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data. | AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 | GE Medical Systems, SCS | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0093-2024"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0093-2024"When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet. | BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-2P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0035-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0035-2025"During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails. | Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 86639P1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0011-2022"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0011-2022"The devices malfunction under specific operator workflows. | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0004-2019"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0004-2019"Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. | TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in tP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0019-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0019-2018"During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. | Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectiP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0078-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0078-2018"The devices have an incorrect firmware configuration. | RESONATE EL ICD DR, Model D433, Sterile. | Boston Scientific Corporation | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0026-2025"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0026-2025"Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0093-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0093-2018"The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered. | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planaP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0080-2018"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0080-2018"The devices have an incorrect firmware configuration. | MOMENTUM X4 CRT-D, Model G138, Sterile. | Boston Scientific Corporation | Class Class IIP1https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0123-2022"https://api.fda.gov/device/enforcement.json?search=recall_number:"Z-0123-2022"Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed. | EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 | Philips Ultrasound Inc | Class ClasP1