Browse Device Recalls
32 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 32 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 32 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2022 | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 10, 2022 | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Jan 10, 2022 | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1... | Class II | Shimadzu Medical Systems |
| Dec 16, 2021 | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Ang... | Class II | Shimadzu Medical Systems |
| Dec 16, 2021 | Digital Angiography System Bransist safire Generator Model D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Ang... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 9, 2020 | Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjust... | There is a potential that the adjustable handle option on the X-Ray system may have been installe... | Class II | Shimadzu Medical Systems |
| Nov 4, 2019 | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained ... | The DAP meters were found to be outside of tolerance. | Class II | Shimadzu Medical Systems |
| Jan 14, 2019 | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product U... | In these units, the brake is usually released by gripping the drive handle and applied by letting... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... | Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is ... | Normal operation of the device is to power up the device in the morning, register the first patie... | Class II | Shimadzu Medical Systems Usa Com |
| Jun 15, 2018 | TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position an... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 12, 2018 | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiograp... | When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or ch... | Class II | Shimadzu Medical Systems |
| May 23, 2017 | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-20... | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 23, 2017 | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ra... | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 23, 2017 | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| Nov 20, 2016 | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of... | Class II | Shimadzu Medical Systems |
| Nov 20, 2016 | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION saf... | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possib... | Class II | Shimadzu Medical Systems |
| Mar 31, 2016 | X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray h... | Report of unintentional movement of table to reverse tilting. | Class II | Shimadzu Medical Systems |
| Nov 10, 2015 | Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a m... | The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image... | Class II | Shimadzu Medical Systems |
| Sep 30, 2015 | Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. | The C-arm may interfere with the table top under certain circumstances. | Class II | Shimadzu Medical Systems |
| Apr 3, 2014 | Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This dev... | Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a ... | Class II | Shimadzu Medical Systems |
| Nov 15, 2013 | Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device i... | Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because... | Class II | Shimadzu Medical Systems |
| Mar 18, 2013 | Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray... | The recall was initiated because Shimadzu Corporation has identified a potential issue in certain... | Class II | Shimadzu Medical Systems |
| Oct 28, 2011 | R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... | Class II | Shimadzu Medical Systems |
| Oct 28, 2011 | 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system i... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... | Class II | Shimadzu Medical Systems |
| Oct 28, 2011 | R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... | Class II | Shimadzu Medical Systems |
| Oct 28, 2011 | 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray sys... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... | Class II | Shimadzu Medical Systems |
| Oct 28, 2011 | 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, Mob... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... | Class II | Shimadzu Medical Systems |
| Oct 28, 2011 | 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileAr... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... | Class II | Shimadzu Medical Systems |
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.