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.

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DateProductReasonClassFirm
Jan 27, 2014 syngo Dynamics Picture Archiving and Communication System (PACS). Model num... Potential patient data mixup. Improper error handling could allow for two different patients to ... Class II Siemens Medical Solutions USA, Inc
Dec 22, 2013 ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 H... The user interface assembly on the ACUSON SC2000 may become loose with the potential for the ent... Class II Siemens Medical Solutions USA, Inc.
Dec 22, 2013 ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical ... The locking mechanism that is intended to hold the control panel in a fixed position can become l... Class II Siemens Medical Solutions USA, Inc.
Dec 16, 2013 Siemens Artis zee Ceiling Systems. Angiographic x-ray system. During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub... Class II Siemens Medical Solutions USA, Inc
Dec 5, 2013 Siemens Artis Q and Artis Q biplane systems Product Usage: Intervention... There exists the possibility that during clinical operation, a breakdown of the x-ray tube could ... Class II Siemens Medical Solutions USA, Inc
Nov 15, 2013 Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition ... During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM D... Class II Siemens Medical Solutions USA, Inc
Oct 28, 2013 Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient c... Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. Class II Siemens Medical Solutions USA, Inc.
Oct 28, 2013 e.cam line of gamma camera systems Used to detect or image the distributi... Reports of loose bolts in the detector support structure of Symbia and e.cam systems. Class II Siemens Medical Solutions USA, Inc.
Sep 11, 2013 The Artis zee / zeego Angiography System is designed as a set of components t... There is a potential issue on running Artis systems running software VC1x software if a network p... Class II Siemens Medical Solutions USA, Inc
Sep 3, 2013 Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software ve... When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... Class II Siemens Medical Solutions USA, Inc
Sep 3, 2013 (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Urosko... A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos... Class II Siemens Medical Solutions USA, Inc
Aug 28, 2013 Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with sof... When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2013 Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the... The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an... Class II Siemens Medical Solutions USA, Inc.
Aug 16, 2013 Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of r... The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an... Class II Siemens Medical Solutions USA, Inc.
Jul 10, 2013 Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M... Software issue results in inaccurate 3D image may result in ablation in wrong location. Class II Siemens Medical Solutions USA, Inc.
Jun 26, 2013 ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21... Siemens issued a customer safety advisory notice and field safety corrective action for a potenti... Class II Siemens Medical Solutions USA, Inc
Jun 10, 2013 syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo... Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the s... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2013 Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003.... Siemens issued a Field Safety Notice about the potential hazard to patients or operators when usi... Class II Siemens Medical Solutions USA, Inc
May 13, 2013 Siemens AXIOM Artis zeego x-ray, angiographic system Siemens issued a customer safety notice about the overlay of system information after a functiona... Class II Siemens Medical Solutions USA, Inc
May 7, 2013 Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system Siemens became aware of an unintended behavior when using the Luminos dRF with software version V... Class II Siemens Medical Solutions USA, Inc
May 6, 2013 Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with sof... Siemens has discovered through product monitoring a potential malfunction when using system opera... Class II Siemens Medical Solutions USA, Inc
May 2, 2013 Mobiletta Mira Mobile X-ray System Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett... Class II Siemens Medical Solutions USA, Inc
Apr 26, 2013 Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic s... The firm became aware of a potential issue with Axiom Artis systems installed by a third party in... Class II Siemens Medical Solutions USA, Inc
Mar 28, 2013 Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that ... When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be ... Class II Siemens Medical Solutions USA, Inc.
Mar 8, 2013 Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license i... The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC2... Class II Siemens Medical Solutions USA, Inc
Mar 4, 2013 Siemens syngo.plaza SW version VA20 with Mammography license. image proce... Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syn... Class II Siemens Medical Solutions USA, Inc
Feb 28, 2013 Siemens Mammomat Inspiration - full-field digital mammography Product Usa... Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility... Class II Siemens Medical Solutions USA, Inc
Jan 31, 2013 Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Pr... During the course of product monitoring, Siemens became aware of a tolerance problem in the power... Class II Siemens Medical Solutions USA, Inc
Jan 21, 2013 Artis zee systems x-ray, angiographic system The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135,... Class II Siemens Medical Solutions USA, Inc
Jan 18, 2013 ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 ... On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. Class II Siemens Medical Solutions USA, Inc.
Jan 15, 2013 Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos... Siemens has become aware of a potential malfunction and possible hazard to patients and staff whe... Class II Siemens Medical Solutions USA, Inc
Nov 27, 2012 Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syn... Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" func... Class II Siemens Medical Solutions USA, Inc
Nov 26, 2012 Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 i... In the course of the firm's product monitoring activities, a potential risk for patient or operat... Class II Siemens Medical Solutions USA, Inc
Oct 23, 2012 The Siemens Symbia T series is intended to aid in detecting, localizing, diag... There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. Class II Siemens Medical Solutions USA, Inc.
Oct 23, 2012 The Siemens Symbia S series is intended to aid in detecting, localizing, diag... There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. Class II Siemens Medical Solutions USA, Inc.
Oct 10, 2012 MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ce... A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 ... Class II Siemens Medical Solutions USA, Inc
Oct 10, 2012 Siemens Mobilette Mira, intended use as Mobile x-ray system. There is a risk of lost images during examination. Class II Siemens Medical Solutions USA, Inc
Oct 5, 2012 Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP... Under certain conditions, when using the Search functionality, the potential exists for the wrong... Class II Siemens Medical Solutions USA, Inc
Sep 12, 2012 Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic R... When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as i... Class II Siemens Medical Solutions USA, Inc
Aug 21, 2012 Siemens Mobilett Mira. Mobile X-Ray System. During regular product monitoring, Siemens has become aware of a potential issue with the Mobilet... Class II Siemens Medical Solutions USA, Inc
Jul 18, 2012 syngo Imaging XS. Radiological image processing system. There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some s... Class II Siemens Medical Solutions USA, Inc
Jul 18, 2012 syngo.plaza, Model number 10592457. Intended use: radiological image proc... There is a potential malfunction in which a miscalculation occurs for images with pixel depth val... Class II Siemens Medical Solutions USA, Inc
Jul 11, 2012 ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model ... In certain situations, loss of post exercise images can occur in Stress Echo. Class II Siemens Medical Solutions USA, Inc.
Jun 20, 2012 Siemens syngo.plaza Radiological Image Processing System Usage: Radiologic... Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instr... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2012 Siemens syngo.plaza radiological image processing system. Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the... Class II Siemens Medical Solutions USA, Inc
May 11, 2012 ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, V... In some cases, the system is unable to capture a clip or image during a routine scan. Class II Siemens Medical Solutions USA, Inc.
Apr 30, 2012 Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray s... During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira ... Class II Siemens Medical Solutions USA, Inc
Apr 30, 2012 Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Urosk... Class II Siemens Medical Solutions USA, Inc
Apr 11, 2012 Symbia E is a multi-purpose SPECT system used to detect or image the distribu... Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class II Siemens Medical Solutions USA, Inc.
Apr 11, 2012 E.CAM emission computed tomography system used to detect or image the distrib... Radial motor drives replaced during a customer service action were incorrectly assembled backwards. 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.