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 |
|---|---|---|---|---|
| Aug 17, 2015 | CIOS ALPHA; image intensified fluoroscopic x-ray system | patient procedure interruption due to a potential system failure | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition Flash; intended to produce cross-sectional images of the b... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition AS, intended to produce cross-sectional images of the body... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2015 | SOMATOM Definition Edge; intended to produce cross-sectional images of the bo... | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Corr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 11, 2015 | Syngo RT Oncologist, an optional accessory to the linear accelerator system a... | This update is intended to provide a software update for the Syngo RT Oncologist, which is curren... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 5, 2015 | ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, P... | A software fix has been released to prevent automatic movement resulting in a collision safety ri... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2015 | Siemens Symbia T Series, a radiological imaging system that is a combination ... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | Siemens Intevo Series system, a radiological imaging system that is a combina... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2015 | Siemens Symbia S Series system, a diagnostic analog or digital detector based... | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 6, 2015 | Syngo.plaza; picture archiving and communications system Product Usage: S... | Potential issue leading to data loss and patient data mix-up | Class II | Siemens Medical Solutions USA, Inc |
| Jun 30, 2015 | Artis zee/ zeego systems; dedicated angiography systems developed for single ... | in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray loc... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy... | When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guideli... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 29, 2015 | Axiom Artis systems, dedicated angiography systems developed for single and b... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Artis Q systems; dedicated angiography systems developed for single and bipl... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Siemens Artis zee systems; dedicated angiography systems developed for singl... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 26, 2015 | e.cam Gamma Camera, an emission computed tomography system. It is intended to... | Potential failure mode related to the radial brake, where the detector was able to drift, led to ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 25, 2015 | ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ op... | Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 25, 2015 | ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with softw... | Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual t... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 11, 2015 | SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and... | During certain clinical workflows safety issues may occur involving monitor assignment order and ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2015 | SOMATOM Emotion 6; produce cross-sectional images of the body by computer rec... | A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2015 | SOMATOM Emotion 16; produce cross-sectional images of the body by computer re... | A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix ... | Class II | Siemens Medical Solutions USA, Inc |
| May 29, 2015 | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A an... | When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of d... | Class II | Siemens Medical Solutions USA, Inc. |
| May 22, 2015 | Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego system... | There exists a possible position sensor fault in the swivel base axis not being detected by the s... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2015 | Syngo.via and Syngo.x ; a software solution intended to be used for viewing, ... | measurements drawn on the 2nd and subsequent images of the series are not visible on printouts wh... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2015 | syngo Workflow SLR; The information system syngo Workflow SLR is a digital ra... | A potential exists for order transactions from interfaced HIS (Hospital Information System) syste... | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2015 | Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ra... | under certain circumstances the Cios Alpha system may freeze during a procedure. | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2015 | ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression,... | potential safety risk of collision of the LINAC gantry with the patient or the treatment table i... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Perspective; the intended use of computed tomography is to produce cr... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Emotion 16, the intended use of computed tomography is to produce cro... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2015 | SOMATOM Emotion 6; the intended use of computed tomography is to produce cros... | Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessar... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 14, 2015 | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray... | If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system,... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fl... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 19, 2015 | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography syst... | potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connectio... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2015 | MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indic... | The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that g... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2015 | Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to... | Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/re... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 6, 2015 | SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA... | Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 21, 2015 | Siemens LANTIS Oncology Information System Servers; allows the radiation the... | There is a potential safety risk when using LANTIS server software with operating systems with wh... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 16, 2015 | Artis One; The Artis One is an angiography system developed for diagnostic in... | The possibility exists that the monitor may fail and requires a power circle (shutdown and then p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 13, 2015 | Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PAC... | In case of a system crash, images may not be written to the hard disk and this may result in inco... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 12, 2015 | ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. ... | There is a low probability the scanner arm will become completely detached from the scanner column. | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 12, 2015 | ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. ... | The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Cont... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 2, 2015 | Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR a... | Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registrat... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 19, 2014 | LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR ... | A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent prot... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 15, 2014 | Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 an... | Potential for composed images to be flipped before being sent to PACS on systems with software v... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 3, 2014 | Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: ... | Suboptimal routing of the cable may result in increased wear over time. Without additional measur... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 3, 2014 | SOMATOM Force; the intended use of computed tomography is to produce cross-se... | Artifacts are found in acquired imaging on the SOMATOM Force. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 2, 2014 | Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus... | Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator ... | 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.