Toshiba American Medical Systems Inc

Complete recall history across all FDA and CPSC categories — 56 total recalls

Toshiba American Medical Systems Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (56)

FDA medical device enforcement actions by Toshiba American Medical Systems Inc. Showing most recent 50.

Date Product Reason Class
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 ... Class II
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... Class II
Dec 29, 2017 INFX-8000H Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation... Class II
Dec 29, 2017 INFX-8000F Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation... Class II
Dec 29, 2017 INFX-8000C Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation... Class II
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 image... Class II
May 1, 2017 APLIO 300 TUS-A300 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Dopple... Class II
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 Dopple... Class II
May 1, 2017 XARIO 100 TUS-X100 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Dopple... Class II
May 1, 2017 APLIO 500 TUS-A500 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Dopple... Class II
May 1, 2017 XARIO 200 TUS-X200 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Dopple... Class II
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
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... Class II
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 b... Class II
Aug 4, 2016 Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultras... Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ul... Class II
May 19, 2016 Toshiba Ultimax DREX-ULT80 X-ray generator It was discovered that the generator of the system could possibly terminate t... Class II
May 19, 2016 Toshiba Kalare DREX-KL80 X-ray generator It was discovered that the generator of the system could possibly terminate t... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
Apr 24, 2016 Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B... Potential degradation of detector performance. Class II
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 M... Class II
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... Class II
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 la... Class II
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 ap... Class II
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 ... Class II
May 8, 2015 Toshiba Aquilion CT System TSX-301B If two specific operations are performed in multi-phase helical scanning, the... Class II
May 8, 2015 Celesteion PCA-9000A/2 PET/CT System It was found that if specific operations are performed in multi-phase helical... Class II
May 8, 2015 Toshiba Aquilion CT System TSX-101A If two specific operations are performed in multi-phase helical scanning, the... Class II
May 8, 2015 Toshiba Aquilion CT System TSX-302A If two specific operations are performed in multi-phase helical scanning, the... Class II
May 8, 2015 Toshiba Aquilion CT System TSX-301A If two specific operations are performed in multi-phase helical scanning, the... Class II
May 8, 2015 Toshiba Aquilion CT System TSX-303A If two specific operations are performed in multi-phase helical scanning, the... Class II
May 8, 2015 Toshiba Aquilion CT System TSX-301C If two specific operations are performed in multi-phase helical scanning, the... Class II
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 en... Class II
Nov 5, 2014 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... Potential problem with the cardiac function analysis software (CFA). Incorre... Class II
Nov 5, 2014 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... Potential problem with the cardiac function analysis software (CFA). Incorre... Class II
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, ... Class II
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 failur... Class II
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... Class II
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 ... Class II
Aug 5, 2013 Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic im... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Syste... Class II
Aug 5, 2013 Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Syste... Class II
Aug 5, 2013 Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Syste... Class II
Aug 5, 2013 Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Syste... Class II
Apr 3, 2013 TOSHIBA Kalare Diagnostic X-Ray System K110785 Firm initiated recall because when radiographic conditions with the small foc... Class II
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 Toshi... Class II
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 generato... Class II
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 acquisiti... Class II
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... Class II

View all 56 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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