FDAJune 15, 2017device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
fujifilm medical systems ufujifilmfujifilm medical
UPCs
04540217052226
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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