The Recall Desk

Manufacturer

Shimadzu Medical Systems Usa Com

7 recalls in our database name Shimadzu Medical Systems Usa Com as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2019-03-27

Of the 7 recalls from Shimadzu Medical Systems Usa Com we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–7 of 7

  • HighFDA (Devices)·Z-1039-2019·2019-03-27

    Shimadzu Mobile X-Ray System Recalled for Brake Failure

    Shimadzu is recalling 93 MobileDaRt Evolution mobile X-ray systems because the brakes may fail to engage when the operator releases the drive handle.

    Product
    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0959-2019·2019-03-06

    Shimadzu BRANSIST safire Digital Angiography System Software Recall

    Shimadzu Medical Systems is recalling eight BRANSIST safire digital angiography systems due to a software error that can cause abnormal termination during initial patient registration.

    Product
    BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2019·2019-02-27

    Shimadzu TRINIAS Imaging Systems Recalled for Software and Display Errors

    Shimadzu is recalling 13 TRINIAS imaging systems due to software crashes and rare display corruption that may hinder medical examinations.

    Product
    TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0197-2019·2018-10-31

    Shimadzu TRINIAS Digital Angiographic System Recalled for C-Arm Movement Issue

    Shimadzu is recalling one TRINIAS Digital Angiographic System in Louisiana due to a software issue that may cause the C-arm to move unexpectedly, posing a risk of contact with patients or staff.

    Product
    TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2654-2017·2017-07-05

    Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks

    Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2017·2017-07-05

    Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks

    Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.

    Product
    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualifie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2017·2017-07-05

    Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks

    Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or
    Category
    Medical Device
    Distribution
    Distributed nationwide