PlainRecalls

Toshiba American Medical Systems Inc

Compiled from official public sources by the publisher.

56 recalls on record · Latest: Jul 4, 2018

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Agency notice ledger

Federal filing book Toshiba American Medical Sy… MID-BOOK · SINGLE-AGENCY

#316 of 14,151 · 56 notices · 0.054% archive

  • BOOK 56 notices
  • RANK #316 of 14,151
  • SHARE 0.054% archive
  • AGENCY FDA Devices (56)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 4, 2018
  • PHOTO Chetak New York LLC

Nearest notice-volume peer: Chetak New York LLC (0 notice gap)

Toshiba American Medical Systems Inc accounts for about 0.054% of the 104,423-notice archive on 56 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Toshiba American Medical Sy… compares to 14,151 recalling firms

Toshiba American Medical Systems Inc ranks 316th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Toshiba American Medical Sy… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

56 316th of 14151 higher than 13,835 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Toshiba American Medical Sy… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Toshiba American Medical Systems Inc holds about 0.054% of archive notices alongside 56 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
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 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 and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications ca
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, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.
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 and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
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 sectional volumes of the whole body, to include the head.
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 system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a pat
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, 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 images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, whi
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 CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is i
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 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 limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
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 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 positioner.
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 TSX-301A/2D 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 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume s
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 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 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, hi
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 interventional setting.
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 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 to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to
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.

Toshiba American Medical Sy… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Synthes USA Hq, Inc. 56 Avanos Medical, Inc. 57 Sedecal Sa 57 Covidien Medtronic 55

Frequently Asked Questions

How many federal recall notices name Toshiba American Medical Sy…? ▼
PlainRecalls indexes 56 distinct federal recall events naming Toshiba American Medical Systems Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Toshiba American Medical Sy… sit among other recalling firms? ▼
Toshiba American Medical Systems Inc ranks #316 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Toshiba American Medical Sy…'s notices? ▼
FDA Devices accounts for 56 of this firm's 56 indexed notices.
What product category dominates Toshiba American Medical Sy…'s filing book? ▼
Filings for Toshiba American Medical Systems Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Toshiba American Medical Systems Inc: 56 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Toshiba American Medical Systems Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026