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 |
|---|---|---|---|---|
| Apr 22, 2020 | ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Pro... | If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Us... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Al... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios A... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2020 | Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10... | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2020 | Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-103... | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 6, 2020 | System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel det... | It was determined that in rare cases persons can receive low dose of unintended radiation. The s... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 6, 2020 | System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat... | It was determined that in rare cases persons can receive low dose of unintended radiation. The s... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versi... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console S... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #585... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2020 | MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, ME... | Potential safety issue with the dose monitoring system safety interlocks which could result in a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Ar... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2020 | Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848... | A software issue could potentially cause the stand and table movements to be blocked. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 10, 2020 | Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray ... | The Ysio system may process incorrect internal values for the position of its ceiling tube stand.... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 24, 2020 | ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 ... | Potential exists for one or more axes of the robotic stand to become blocked by their safety brak... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 16, 2020 | COHERENCE Oncologist, Model Nos. 07333680 & 07351898 | A potential safety issue arises when an offset calculation is followed by a filter operation; cor... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a d... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a dev... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a dev... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic ... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Mod... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 20, 2019 | Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray Sys... | The potential exists for system movement to be permanently blocked by an activation of the collis... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 25, 2019 | Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X... | During a routine inspection of a system, a crack on the C-arm holder was discovered. In the even... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 14, 2019 | Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 1009... | In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collis... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 7, 2019 | Software versions syngo CT VB20 running on the following Siemens SOMATOM CT ... | Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanne... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 24, 2019 | SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061630 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography ... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061638 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This compute... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Top; Models #11061648 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Top; Models #11061640 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 30, 2019 | Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with p... | Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 25, 2019 | syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomog... | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 23, 2019 | Mammomat Revelation with software version VC10 and Biopsy Option Intended ... | An error can occur when performing a biopsy using the InSpect function. The acquisition workstati... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 10, 2019 | Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is t... | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 9, 2019 | MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 | Potential of an open port in the quench venting system when using the optional horizontal outlet ... | 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.