Browse Device Recalls
168 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 168 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 168 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 14, 2024 | SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Nov 16, 2022 | B125M Patient Monitor, REF 6160000-005-XXXXXXX | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... | Class II | GE Medical Systems, LLC |
| Nov 16, 2022 | B105M Patient Monitor, REF 6160000-003 | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... | Class II | GE Medical Systems, LLC |
| Nov 16, 2022 | B125P Patient Monitor (with E-module slot option), REF 6160000-002 | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... | Class II | GE Medical Systems, LLC |
| Nov 16, 2022 | B125M Patient Monitor, REF 6160000-004-XXXXXX | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... | Class II | GE Medical Systems, LLC |
| Nov 16, 2022 | B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging ... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imagin... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obs... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K0... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Nov 10, 2022 | Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Ob... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... | Class II | GE Medical Systems, LLC |
| Oct 28, 2022 | Centricity PACS-IW with Universal Viewer version 5.0. Used to display me... | There is the potential that after installation of the IAS tool, some studies can remain hidden wi... | Class II | GE Medical Systems, LLC |
| Oct 28, 2022 | Centricity Universal Viewer 6.0. Used to display medical images (Includi... | There is the potential that after installation of the IAS tool, some studies can remain hidden wi... | Class II | GE Medical Systems, LLC |
| Oct 3, 2018 | SIGNA Architect system Product Usage: The Signa Architect system is a who... | A small area on the bore surface, which is normally accessible to the patient, can get warm enoug... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 7, 2018 | GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr... | The latest on-site software version may not have been reinstalled at some sites after service act... | Class II | GE Medical Systems, LLC |
| Jun 6, 2018 | Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the fol... | GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclea... | Class II | GE Medical Systems, LLC |
| Mar 30, 2018 | MR Surgical Suite Option Product The MR Surgical Option when integrated wi... | There is a potential safety issue with the table transfer release of the MR Surgical Suite System... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is ... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system co... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGN... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, ... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage:... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whol... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| May 11, 2017 | Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 ... | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... | Class II | GE Medical Systems, LLC |
| Apr 20, 2016 | GE, Revolution CT. The system is intended for head, whole body, cardiac, and... | An out of tolerance torque tool was used on three joints during the manufacturing process. If the... | Class II | GE Medical Systems, LLC |
| Apr 15, 2016 | GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscop... | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... | Class II | GE Medical Systems, LLC |
| Apr 15, 2016 | GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscop... | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experie... | Class II | GE Medical Systems, LLC |
| Mar 15, 2016 | GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation... | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 2... | Class II | GE Medical Systems, LLC |
| Mar 1, 2016 | SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body... | Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction... | Class II | GE Medical Systems, LLC |
| Feb 17, 2016 | GE Healthcare, Aisys Carestation. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 17, 2016 | GE Healthcare, Aisys CS2 anesthesia.. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSp... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The Ligh... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.