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 |
|---|---|---|---|---|
| May 1, 2018 | Artis zee MP, Material no. 10094139, for angiography and whole body radiograp... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zeego, Material no. 10280959 , for angiography and whole body radiogra... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zee biplane MN, Material no. 10094143, for angiography and whole body r... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 | If the C-arm is manually moved in the longitudinal direction to a fully extended position, the sy... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q ceiling, Material no. 10848281, for angiography and whole body radiog... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q biplane, Material no. 10848282, for angiography and whole body radiog... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q.zeego, Material no. 10848283, for angiography and whole body radiogra... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q.zen floor, Material no. 10848353, for angiography and whole body radi... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2018 | SOMATOM go.Now, Material Number 11061618 There is a potential for a softw... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2018 | SOMATOM Go.Up, Material Number 11061628 There is a potential for a softwar... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Mar 27, 2018 | Syngo.Via VB20A model 1049610 | Functionality in the report sections "Findings Information" and "Summary of Measured Findings" no... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2018 | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medic... | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 21, 2018 | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provi... | Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET c... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 20, 2018 | Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communicati... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2018 | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syn... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation 16 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation 10 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by... | To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of th... | To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Perspective 16 Intended to produce cross-sections images of the bo... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion 16 Intended to produce cross-sections images of the body b... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Scope Power Intended to produce cross-sections images of the body ... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation Cardiac Intended to produce cross-sections images of the... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation 40 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Perspective Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion (2003) Intended to produce cross-sections images of the bo... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation 64 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Scope Intended to produce cross-sections images of the body by com... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation Open Intended to produce cross-sections images of the bo... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Spirit Intended to produce cross-sections images of the body by co... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product U... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Prod... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 019400... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Scope ( Model 10967666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 16 (10165977) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Spirit(Model 10045692 ) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Scope Power (Model 10967888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective (Model 10495568) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective 16 (Model 10891666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 6 (Model 10165888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Jan 26, 2018 | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imag... | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 26, 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray di... | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values ar... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 12, 2018 | Artis one fluoroscopic x-ray system and patient table Artis one is an an... | Certain patient table systems may have a missing or incorrectly installed snap ring that could ca... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 10, 2018 | Syngo.via software is intended to be used for viewing, manipulation, communic... | When the archiving configuration is changed, data received/created after the upgrade may be flagg... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2018 | Syngo.via. Medical Device Software. Picture archiving and communications sys... | A software functionality in the report sections Findings Information and Summary of Measured F... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 5, 2018 | AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 77283... | Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 8, 2017 | SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system | There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... | 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.