Reported Dec 20, 2017 · Terminated
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343
Is this the product you have?
- FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200
- CatalogVisionary 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
- Lot codes and dates
- UDI
(01)04540217052226(21)MP95A9F6B001(01)04540217052226(21)MP95A9F6A001(01)04540217052226(21)MP95A8F5A001
- Serial NumbersFDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001
- UDI
- Amount recalled
- 3
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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