Browse Device Recalls
56 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 56 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 56 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2018 | Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 ... | The power supply unit may be damaged and may fail to start up when the power plug is inserted int... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000H Fluoroscopic X-Ray Systems | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000F Fluoroscopic X-Ray Systems | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000C Fluoroscopic X-Ray Systems | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Sep 12, 2017 | Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is ... | During an examination images were displayed on the live monitor,but the images were not displayed... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | APLIO 300 TUS-A300 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic... | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | XARIO 100 TUS-X100 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | APLIO 500 TUS-A500 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | XARIO 200 TUS-X200 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| Mar 15, 2017 | Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Mo... | The issue was identified as a firmware problem with the generator. | Class II | Toshiba American Medical Systems Inc |
| Feb 1, 2017 | Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System ... | It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Trackin... | Class II | Toshiba American Medical Systems Inc |
| Oct 25, 2016 | Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system wit... | Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been ... | Class II | Toshiba American Medical Systems Inc |
| Aug 4, 2016 | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultras... | Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System beca... | Class II | Toshiba American Medical Systems Inc |
| May 19, 2016 | Toshiba Ultimax DREX-ULT80 X-ray generator | It was discovered that the generator of the system could possibly terminate the exposure prematur... | Class II | Toshiba American Medical Systems Inc |
| May 19, 2016 | Toshiba Kalare DREX-KL80 X-ray generator | It was discovered that the generator of the system could possibly terminate the exposure prematur... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scann... | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 24, 2016 | Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B... | Potential degradation of detector performance. | Class II | Toshiba American Medical Systems Inc |
| Apr 14, 2016 | MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product U... | A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. | Class II | Toshiba American Medical Systems Inc |
| Apr 12, 2016 | Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-03... | Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem w... | Class II | Toshiba American Medical Systems Inc |
| Feb 24, 2016 | Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, a... | During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS ex... | Class II | Toshiba American Medical Systems Inc |
| Jan 14, 2016 | Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is i... | When a user performed radiography using the wireless FPD, a message window appeared on the monit... | Class II | Toshiba American Medical Systems Inc |
| Aug 14, 2015 | INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems | When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose m... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Toshiba Aquilion CT System TSX-301B | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Celesteion PCA-9000A/2 PET/CT System | It was found that if specific operations are performed in multi-phase helical scanning, the acqui... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Toshiba Aquilion CT System TSX-101A | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Toshiba Aquilion CT System TSX-302A | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Toshiba Aquilion CT System TSX-301A | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Toshiba Aquilion CT System TSX-303A | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems Inc |
| May 8, 2015 | Toshiba Aquilion CT System TSX-301C | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems Inc |
| Mar 11, 2015 | INFX-8000V Interventional Angiography System. CAT-880B catheterization table... | The table base rotational brake that holds the table top may not always be engaged when any force... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| May 12, 2014 | Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system ... | Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is... | Class II | Toshiba American Medical Systems Inc |
| Dec 11, 2013 | TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. | Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used ... | Class II | Toshiba American Medical Systems Inc |
| Oct 28, 2013 | Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. | Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absor... | Class II | Toshiba American Medical Systems Inc |
| Oct 1, 2013 | TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquil... | Toshiba intitiated this recall because their investigation revealed that due to a problem of the ... | Class II | Toshiba American Medical Systems Inc |
| Aug 5, 2013 | Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic im... | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... | Class II | Toshiba American Medical Systems Inc |
| Aug 5, 2013 | Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic... | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... | Class II | Toshiba American Medical Systems Inc |
| Aug 5, 2013 | Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic... | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... | Class II | Toshiba American Medical Systems Inc |
| Aug 5, 2013 | Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic... | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... | Class II | Toshiba American Medical Systems Inc |
| Apr 3, 2013 | TOSHIBA Kalare Diagnostic X-Ray System K110785 | Firm initiated recall because when radiographic conditions with the small focus are set and the r... | Class II | Toshiba American Medical Systems Inc |
| Dec 11, 2012 | Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Lis... | Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-... | Class II | Toshiba American Medical Systems Inc |
| Nov 14, 2012 | Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system ... | Due to a problem with the control software of the x-ray high-voltage generator, if scanning is pe... | Class II | Toshiba American Medical Systems Inc |
| Nov 8, 2012 | Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system... | Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option ... | Class II | Toshiba American Medical Systems Inc |
| Oct 15, 2012 | MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Produ... | It was found that there is a problem with the LCD monitor used in the console. The LCD monitor ma... | Class II | Toshiba American Medical Systems 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.