PlainRecalls

Toshiba American Medical Systems Inc

Compiled from official public sources by the editorial team.

56 recalls on record · Latest: Jul 4, 2018

Toshiba American Medical Systems Inc Recall Insight

Toshiba American Medical Systems Inc appears on 56 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.055% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 4, 2018, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Apr 17, 2013 to Jul 4, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jul 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 …

FDA Devices Moderate Mar 14, 2018

INFX-8000C Fluoroscopic X-Ray Systems

FDA Devices Moderate Mar 14, 2018

INFX-8000F Fluoroscopic X-Ray Systems

FDA Devices Moderate Mar 14, 2018

INFX-8000H Fluoroscopic X-Ray Systems

FDA Devices Moderate Mar 14, 2018

INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

FDA Devices Moderate Oct 25, 2017

Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiogr…

FDA Devices Moderate Sep 6, 2017

Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vasc…

FDA Devices Moderate Jul 19, 2017

XARIO 200 TUS-X200 diagnostic ultrasound system

FDA Devices Moderate Jul 19, 2017

APLIO 500 TUS-A500 diagnostic ultrasound system

FDA Devices Moderate Jul 19, 2017

XARIO 100 TUS-X100 diagnostic ultrasound system

FDA Devices Moderate Jul 19, 2017

APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system

FDA Devices Moderate Jul 19, 2017

APLIO 300 TUS-A300 diagnostic ultrasound system

FDA Devices Moderate Jun 7, 2017

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

FDA Devices Moderate Mar 22, 2017

Toshiba Kalare DREX-KL80 X-ray generator

FDA Devices Moderate Mar 22, 2017

Toshiba Ultimax DREX-ULT80 X-ray generator

FDA Devices Moderate Nov 30, 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 …

FDA Devices Moderate Oct 12, 2016

Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross …

FDA Devices Moderate Oct 12, 2016

Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

FDA Devices Moderate Oct 12, 2016

Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

FDA Devices Moderate Oct 12, 2016

Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

FDA Devices Moderate Aug 24, 2016

Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.

FDA Devices Moderate Jul 27, 2016

Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System

FDA Devices Moderate Jul 13, 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 …

FDA Devices Moderate May 11, 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, an…

FDA Devices Moderate May 4, 2016

Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical …

FDA Devices Moderate Mar 30, 2016

Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage ge…

FDA Devices Moderate Feb 17, 2016

INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems

FDA Devices Moderate Oct 21, 2015

Toshiba Aquilion CT System TSX-301C

FDA Devices Moderate Oct 21, 2015

Toshiba Aquilion CT System TSX-303A

FDA Devices Moderate Oct 21, 2015

Toshiba Aquilion CT System TSX-301A

FDA Devices Moderate Oct 21, 2015

Toshiba Aquilion CT System TSX-302A

FDA Devices Moderate Oct 21, 2015

Toshiba Aquilion CT System TSX-101A

FDA Devices Moderate Oct 21, 2015

Toshiba Aquilion CT System TSX-301B

FDA Devices Moderate Oct 14, 2015

Celesteion PCA-9000A/2 PET/CT System

FDA Devices Moderate Apr 15, 2015

INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorograph…

FDA Devices Moderate Dec 3, 2014

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE…

FDA Devices Moderate Dec 3, 2014

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE T…

FDA Devices Moderate Jun 11, 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 inte…

FDA Devices Moderate Mar 12, 2014

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

FDA Devices Moderate Mar 12, 2014

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…

FDA Devices Moderate Nov 20, 2013

Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.

FDA Devices Moderate Nov 6, 2013

Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging

FDA Devices Moderate Nov 6, 2013

Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging

FDA Devices Moderate Nov 6, 2013

Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging

FDA Devices Moderate Nov 6, 2013

Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging

FDA Devices Moderate Jul 17, 2013

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Devices Moderate Apr 24, 2013

Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

FDA Devices Moderate Apr 17, 2013

MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

FDA Devices Moderate Apr 17, 2013

Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

FDA Devices Moderate Apr 17, 2013

TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.