Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2017 - (Recall #: Z-0232-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.

Product Classification:

Class II

Date Initiated: June 15, 2017

Date Posted: December 20, 2017

Recall Number: Z-0232-2018

Event ID: 78644

Reason for Recall:

A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

Status: Terminated

Product Quantity: 3

Code Information:

UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001. Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001

Distribution Pattern:

US Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated