Toshiba American Medical Systems Inc: FDA recalls

FDA enforcement reports name Toshiba American Medical Systems Inc as the recalling firm in 36 events. The events have 56 product records. The recalls started from 2008 to 2018. All the events are device recalls.

See the 36 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

36 events, newest first.

FDA enforcement events of Toshiba American Medical Systems Inc
Initiated	Product (first record)	Type	Class	Records	Status
4 Jan 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 into a power outlet while the main power switch on the rear of the system is set to ON.	Device	Class II	1	Terminated
29 Dec 2017	INFX-8000F Fluoroscopic X-Ray Systems	Device	Class II	4	Terminated
12 Sep 2017	Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult…	Device	Class II	1	Terminated
1 May 2017	XARIO 100 TUS-X100 diagnostic ultrasound system	Device	Class II	5	Terminated
15 Mar 2017	Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic…	Device	Class II	1	Terminated
1 Feb 2017	Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F	Device	Class II	1	Terminated
25 Oct 2016	Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.	Device	Class II	1	Terminated
4 Aug 2016	Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.	Device	Class II	1	Terminated
19 May 2016	Toshiba Kalare DREX-KL80 X-ray generator	Device	Class II	2	Terminated
25 Apr 2016	Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.	Device	Class II	4	Terminated
24 Apr 2016	Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D…	Device	Class II	1	Terminated
14 Apr 2016	MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore…	Device	Class II	1	Terminated
12 Apr 2016	Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshiba’s innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the…	Device	Class II	1	Terminated
24 Feb 2016	Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System	Device	Class II	1	Terminated
14 Jan 2016	Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and…	Device	Class II	1	Terminated
14 Aug 2015	INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems	Device	Class II	1	Terminated
8 May 2015	Celesteion PCA-9000A/2 PET/CT System	Device	Class II	1	Terminated
8 May 2015	Toshiba Aquilion CT System TSX-101A	Device	Class II	6	Terminated
11 Mar 2015	INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis…	Device	Class II	1	Terminated
5 Nov 2014	Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of…	Device	Class II	2	Terminated
12 May 2014	Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.	Device	Class II	1	Terminated
11 Dec 2013	TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.	Device	Class II	1	Terminated
28 Oct 2013	Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.	Device	Class II	1	Terminated
1 Oct 2013	TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated…	Device	Class II	1	Terminated
5 Aug 2013	Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging	Device	Class II	4	Terminated
3 Apr 2013	TOSHIBA Kalare Diagnostic X-Ray System K110785	Device	Class II	1	Terminated
11 Dec 2012	Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.	Device	Class II	1	Terminated
14 Nov 2012	Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.	Device	Class II	1	Terminated
8 Nov 2012	Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.	Device	Class II	1	Terminated
15 Oct 2012	MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.	Device	Class II	1	Terminated
21 Feb 2012	Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.	Device	Class II	1	Terminated
30 Nov 2011	TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.	Device	Class II	1	Terminated
13 Jul 2009	Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.	Device	Class II	1	Terminated
13 May 2008	TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of…	Device	Class II	1	Terminated
13 May 2008	EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.	Device	Class II	1	Terminated
27 Feb 2008	Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Toshiba American Medical Systems Inc: events for each product type
Type		Events
Device		36

Toshiba American Medical Systems Inc: events in each class
Class		Events
Class II		36

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Toshiba American Medical Systems Inc, by the year that the recall started. The largest year is 2016, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Toshiba American Medical Systems Inc: FDA recalls. https://recallregister.com/firm/toshiba-american-medical-systems-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Toshiba American Medical Systems Inc have?: Class II: 36 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Toshiba American Medical Systems Inc?: FDA event 80019, which the firm started on 4 Jan 2018. The first product in the record is: 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 into a power outlet while the main power switch on the rear of the system is set to ON.
How many FDA recalls of Toshiba American Medical Systems Inc have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.