The Recall Desk

Manufacturer

Toshiba American Medical Systems Inc

56 recalls in our database name Toshiba American Medical Systems Inc as the manufacturing or recalling firm.

What the numbers show

Total
56
Critical
0
Severe
2
Most recent
2018-07-04

Of the 56 recalls from Toshiba American Medical Systems Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 56

  • ModerateFDA (Devices)·Z-1175-2016·2016-03-30

    Toshiba DRAD-3000E Wireless System Recalled for Image Transmission Failure

    Toshiba is recalling 28 DRAD-3000E FPD Wireless Systems because they fail to complete image transmission, resulting in no radiographic image.

    Product
    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 h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0752-2016·2016-02-17

    Toshiba INFX-8000V X-Ray System Recalled for Dose Meter Error

    Toshiba is recalling four INFX-8000V Bi-Plane X-Ray Interventional Systems because a software error caused dose data to be lost during specific imaging procedures.

    Product
    INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0016-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Potential Data Loss

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301C
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0015-2016·2015-10-21

    Toshiba Aquilion CT System Recalled for Data Loss Risk

    Toshiba American Medical Systems is recalling 459 Aquilion CT Systems because specific scanning operations may cause raw data to not be saved.

    Product
    Toshiba Aquilion CT System TSX-301B
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0013-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-101A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0018-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired raw data to not be saved.

    Product
    Toshiba Aquilion CT System TSX-303A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0017-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-302A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0005-2016·2015-10-14

    Toshiba Recalls Celesteion PET/CT Systems Due to Data Loss Risk

    Toshiba American Medical Systems is recalling one Celesteion PCA-9000A/2 PET/CT System in Nevada because a software defect may prevent raw data from being saved during specific scans.

    Product
    Celesteion PCA-9000A/2 PET/CT System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1394-2015·2015-04-15

    Toshiba INFX-8000V Interventional Angiography System Recall for Brake Defect

    Toshiba is recalling 28 INFX-8000V Interventional Angiography Systems because the table base rotational brake may not engage when force is applied to the table top.

    Product
    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 se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0472-2015·2014-12-03

    Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results

    Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.

    Product
    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 perm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2015·2014-12-03

    Toshiba Cardiac Function Analysis Software Recalled for Incorrect Results

    Toshiba American Medical Systems is recalling one unit of cardiac function analysis software in the US because it may display incorrect analysis results.

    Product
    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 sca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1714-2014·2014-06-11

    Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue

    Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1113-2014·2014-03-12

    Toshiba CT Systems Recalled for X-Ray Output Software Defect

    Toshiba is recalling 338 Aquilion CT systems because a software defect may prevent X-ray exposure from starting during contrast studies.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0972-2014·2014-03-12

    Toshiba CT System Recalled Due to X-Ray Generator Failure

    Toshiba is recalling eight Aquilion One CT systems because high-voltage generator parts may fail, preventing X-ray exposure.

    Product
    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0201-2014·2013-11-20

    Toshiba Titan 3T MRI System Recalled for SAR Display Error

    Toshiba is recalling 18 Titan 3T MRI systems because they may display lower Specific Absorption Rate (SAR) values than actual when used with specific coils.

    Product
    Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 430 diagnostic ultrasound systems because the transducer head may overheat under specific operating conditions.

    Product
    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 477 Xario XG Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.

    Product
    Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.

    Product
    Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating Risk

    Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.

    Product
    Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2013·2013-07-17

    Toshiba Kalare Diagnostic X-Ray System Recalled for Image Quality Defect

    Toshiba American Medical Systems is recalling 153 Kalare Diagnostic X-Ray Systems because the large focus heats up unexpectedly, causing brighter images than expected.

    Product
    TOSHIBA Kalare Diagnostic X-Ray System K110785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2013·2013-04-24

    Toshiba Diagnostic Ultrasound Systems Recalled for Startup Issues

    Toshiba is recalling 233 Aplio 500/400/300 diagnostic ultrasound systems due to startup issues that may cause system damage.

    Product
    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1101-2013·2013-04-17

    Toshiba MRI Systems Recalled for LCD Monitor Backlight Failure

    Toshiba American Medical Systems is recalling 27 Titan X and Titan 3T MRI systems because the console LCD monitor backlight may turn off during use.

    Product
    MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2013·2013-04-17

    Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error

    Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.

    Product
    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2013·2013-04-17

    Toshiba CT System Recalled for Software Error in Low-Current Scans

    Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.

    Product
    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
    Category
    Medical Device
    Distribution
    1 state