Browse Device Recalls
702 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 702 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 702 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 2, 2016 | Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images ... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of ... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash a... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition: Intended to produce cross-sectional images of the... | Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients wit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 26, 2016 | system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, ... | In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cab... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 26, 2016 | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera syst... | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 26, 2016 | The Symbia gamma camera system Product Usage: The Symbia gamma camera sy... | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 24, 2016 | syngo X Workplace is a medical workstation for real-time viewing, image manip... | After importing, the segmentation results appear mirrored at the CARTO system and can't be used f... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2016 | AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic i... | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. T... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2016 | Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnost... | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. T... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2016 | Cios Alpha, mobile X-ray system | Software issues on Cios Alpha mobile C-Arm system | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM A... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM A... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 16, 2016 | CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: Th... | Siemens found a defective part in their production line which could increase risk of an electrica... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems ... | Siemens is initiating this recall due to a potential malfunction and hence potential hazard to pa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 12, 2016 | Mammomat Inspiration with Tomosynthesis functionality | A potential system fatal error may occur during tomosynthesis reconstruction with large breasts t... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 29, 2016 | software for Syngo Dynamics a Picture Archiving and Communication System ... | Siemens is releasing a software update that addresses an issue of mixing data from multiple patie... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2016 | Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Mo... | Siemens' conducting a recall due to a potential issue when using the measurement package of the V... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 18, 2016 | A Picture Archiving and Communication System (PACS) intended to display, proc... | To inform users about the possible incorrect values for Distance Measurements when using certain ... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 31, 2015 | The e.cam Dual Signature Gamma Camera system. Used to detect or image the di... | To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not ... | Class II | Siemens Medical Solutions USA, Inc. |
| Dec 22, 2015 | Syngo Plaza Picture archiving and communication system. Software only. PACS... | Siemens is releasing an updated software version to address several software issues including RGB... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 7, 2015 | MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). | Possible installation error of the quench lines of superconducting magnets, used to vent helium g... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 18, 2015 | Software version VD10E for Syngo X-Workplace; Picture archiving and communica... | Potential post-processing software issue when using tabcard "4D" on X-Workplace with software ver... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 17, 2015 | Syngo Imaging XS is a Picture Archiving and Communication System (PACS) | For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in inco... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 30, 2015 | Artis systems with large display from Siemens Medical Solutions USA, Inc. In... | Due to improper soldering in a limited number of large display bypass module components of a spec... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 28, 2015 | Syngo Imaging VB36D_HF02. Radiological image processing system. | To provide supplementary information regarding the release of the syngo Imaging Software Version ... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 7, 2015 | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that pro... | Siemens will provide all customers a new version of system software (VA35E or VB10C depending on ... | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 24, 2015 | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. | Display freeze of MODULARIS hand control results in information not being updated on the display.... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 5, 2015 | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: ... | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON ... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 19, 2015 | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Mode... | The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 18, 2015 | SOMATOM Force; computed tomography x-ray system. Intended to generate and ... | Software and firmware bugs | Class II | Siemens Medical Solutions USA, Inc |
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.