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.

1–25 of 56

  • ModerateFDA (Devices)·Z-2315-2018·2018-07-04

    Toshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect

    Toshiba is recalling 162 Aplio I-series diagnostic ultrasound systems because the power supply unit may be damaged and fail to start up.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2018·2018-03-14

    Toshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening

    Toshiba American Medical Systems is recalling 29 INFX-8000V and INFINIX CF-I/BP PLUS systems because fastening bolts on the ceiling drive loosened, disabling operation.

    Product
    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0843-2018·2018-03-14

    Toshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect

    Toshiba American Medical Systems Inc is recalling 19 INFX-8000C Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.

    Product
    INFX-8000C Fluoroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0012-2018·2017-10-25

    Toshiba Medical Kalare Fluoroscopic X-Ray System Recalled for Image Display Failure

    Toshiba American Medical Systems Inc is recalling 96 Kalare Fluoroscopic X-Ray Systems because images may fail to display on the system monitor or save to the hard disk.

    Product
    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/trai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3070-2017·2017-09-06

    Toshiba Ultimax Digital Fluoroscopic X-Ray System Recalled for Firmware Issue

    Toshiba is recalling 18 Ultimax Digital Fluoroscopic X-Ray Systems due to a firmware problem with the generator.

    Product
    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-e
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2712-2017·2017-07-19

    Toshiba APLIO i-series Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.

    Product
    APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2709-2017·2017-07-19

    Toshiba XARIO 200 Ultrasound System Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems is recalling XARIO 200 diagnostic ultrasound systems because the Continuous Trace method may display incorrect velocity trace values.

    Product
    XARIO 200 TUS-X200 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2017·2017-07-19

    Toshiba APLIO 500 Ultrasound Systems Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.

    Product
    APLIO 500 TUS-A500 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2708-2017·2017-07-19

    Toshiba XARIO 100 Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba American Medical Systems is recalling seven XARIO 100 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method for velocity measurements.

    Product
    XARIO 100 TUS-X100 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2017·2017-06-07

    Toshiba Angio WorkStation Recalled for Dose Tracking Display Error

    Toshiba is recalling 70 Angio WorkStation units because the Peak Skin Dose value may display incorrectly if the workstation is powered on after the Infinix system.

    Product
    Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1398-2017·2017-03-22

    Toshiba Ultimax X-ray generator recalled for premature exposure termination

    Toshiba American Medical Systems is recalling 254 Ultimax DREX-ULT80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Ultimax DREX-ULT80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2017·2017-03-22

    Toshiba Kalare X-ray Generator Recalled for Premature Exposure Termination

    Toshiba American Medical Systems Inc is recalling 254 Kalare DREX-KL80 X-ray generators because the system may terminate exposure prematurely during an examination.

    Product
    Toshiba Kalare DREX-KL80 X-ray generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2017·2016-11-30

    Toshiba Aquilion Prime CT System Recalled for Cooling Oil Leak Risk

    Toshiba American Medical Systems is recalling Aquilion Prime CT systems because cooling oil in the x-ray tube heat exchanger may leak during operation.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2017·2016-10-12

    Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0047-2017·2016-10-12

    Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans if the range exceeds the maximum field of view.

    Product
    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.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0046-2017·2016-10-12

    Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error

    Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.

    Product
    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0049-2017·2016-10-12

    Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors

    Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum field of view.

    Product
    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2542-2016·2016-08-24

    Toshiba Recalls Xario Ultrasound Systems Due to Overheating Software Error

    Toshiba American Medical Systems is recalling 93 Xario 100 and 200 Diagnostic Ultrasound Systems because a software error may cause the devices to become hot.

    Product
    Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2188-2016·2016-07-27

    Toshiba Angio WorkStation Recalled for Incorrect Skin Dose Calculation

    Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.

    Product
    Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2135-2016·2016-07-13

    Toshiba Vantage Titan 3T MRI System Recalled for Gradient Coil Issue

    Toshiba American Medical Systems is recalling 33 Vantage Titan 3T MRI systems due to a potential problem with the gradient coil.

    Product
    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 featur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1607-2016·2016-05-11

    Toshiba Celesteion PET/CT Systems Recalled for Detector Performance Degradation

    Toshiba American Medical Systems is recalling three Celesteion PET/CT systems due to potential degradation of detector performance.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1560-2016·2016-05-04

    Toshiba Recalls Aquilion Lightning CT System iStation Cover

    Toshiba American Medical Systems is recalling the Aquilion Lightning CT System iStation cover because it may fall off the gantry.

    Product
    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 reconstr
    Category
    Medical Device
    Distribution
    1 state