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 |
|---|---|---|---|---|
| Nov 8, 2017 | SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnosti... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnosti... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic sy... | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 7, 2017 | Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To det... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 7, 2017 | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To de... | The Broad Quantification option of the Symbia product software version VB20A may not allow modifi... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 2, 2017 | SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 110... | The table may become unstable if the nuts on the bolts were not adequately tightened and thus hav... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 2, 2017 | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 1106... | The table may become unstable if the nuts on the bolts were not adequately tightened and thus hav... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Mo... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot swit... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foo... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 18, 2017 | Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Inte... | The torque wrench used to tighten system bolts during installation was found to be out of tolerance | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 31, 2017 | Syngo.via systems with SW VB20A | A software update was released on August 22, 2017. Performing this software installation and upgr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 24, 2017 | AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family ... | Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ce... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 23, 2017 | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 1086317... | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Dis... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 22, 2017 | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Intervent... | The possibility exists for the monitor display of Artis one systems with a DP Transceiver below r... | Class II | Siemens Medical Solutions USA, INC |
| Aug 18, 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software v... | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 25, 2017 | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Commu... | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 6, 2017 | Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 1... | Potential for liquid entry | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2017 | Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10... | Potential for liquid entry | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2017 | Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007... | Potential for liquid entry | Class II | Siemens Medical Solutions USA, Inc |
| May 22, 2017 | Syngo.plaza, Picture Archiving and Communications System(PACS), Model 1086317... | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. ... | Class II | Siemens Medical Solutions USA, Inc |
| May 16, 2017 | Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 109... | Software error. In Sensis Vibe systems with software version VD10B, a software error can result ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 12, 2017 | AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a... | An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Per... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 30, 2017 | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... | When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 28, 2017 | Artis zee, Angiographic x-ray system | Software error - As a result of a software fault in Artis zee systems with software version VD11 ... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 6, 2017 | Syngo.via, Picture archiving and communication system Syngo via is a softwar... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 6, 2017 | Syngo.x, Picture archiving and communication system Syngo via is a software ... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2017 | Axiom Artis fluoroscopic x-ray system | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2017 | Artis Zee and Zeego fluoroscopic x-ray system | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2017 | Artis Q and Q.Zen fluoroscopic x-ray system | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 22, 2017 | ARTIS Q, Interventional Fluroscopic x-ray system | In Artis systems with A100G generators, a component can be affected by aging which could result i... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2017 | Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... | Software updates | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ARTISTE" MV System | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | Mevatron M2/Primus Mid-Energy PRIMUS HI | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Expression ONCOR" Impression ONCOR" Impression plus | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Avant-garde | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 3, 2017 | Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angi... | Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SI... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of t... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | PRIMUS Medical charged-particle radiation therapy system Product Usage: T... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical Th... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ARTISTE MV System, medical charged-particle radiation therapy system Produ... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ONCOR Avant-garde, medical charged-particle radiation therapy system Produ... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2017 | Syngo.plaza, picture archiving and communications system. | Software update for improvements and to resolve several issues | Class II | Siemens Medical Solutions USA, Inc |
| Jan 11, 2017 | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product... | Software error | Class II | Siemens Medical Solutions USA, Inc |
| Dec 8, 2016 | Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis syst... | Siemens initiated a corrective action to address two possible, mutually independent causes of a s... | 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.