Browse Device Recalls

710 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 710 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 710 FDA device recalls.

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DateProductReasonClassFirm
May 9, 2016 Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... Software error in previous software versions in which two references for the same image may exist... Class II Siemens Medical Solutions USA, Inc
Apr 14, 2016 Syngo Dynamics; Kinetdx Picture Archiving and Communications System Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syng... Class II Siemens Medical Solutions USA, Inc
Apr 13, 2016 MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, M... The docking station top cover of the removable patient table may contain a magnetic metal plate. ... Class II Siemens Medical Solutions USA, Inc
Apr 8, 2016 ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... Class II Siemens Medical Solutions USA, Inc.
Apr 1, 2016 SOMATOM Force, Computed Tomography x-ray system intended to generate and ... The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly l... Class II Siemens Medical Solutions USA, Inc
Mar 31, 2016 E.cam or Symbia systems that use foresight detectors - Product Usage: To dete... E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may los... Class II Siemens Medical Solutions USA, Inc.
Mar 22, 2016 SOMATOM Definition AS, a family of CT systems intended to produce cross-secti... Siemens became aware that the front cover on some Siemens CT system was not properly welded. It ... Class II Siemens Medical Solutions USA, Inc
Mar 11, 2016 Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiog... After importing segmentation results of the left atrium created on the Artis One system, the poss... Class II Siemens Medical Solutions USA, Inc
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

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.