The Recall Desk

FDA (Devices) recall action 77351

Shimadzu Medical Systems Usa Com recalled 3 products on 2017-07-05

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-07-05
Critical
0
Units
5,019

Why these products were recalled

Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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
    Distribution
    27 states
  • HighFDA (Devices)··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
    Distribution
    27 states
  • HighFDA (Devices)··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
    Distribution
    27 states