FUJIFILM FDR Visionary Suite with CH-200 recall
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to…
Why was FUJIFILM FDR Visionary Suite with CH-200 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001. Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001
- Product
- FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 3
- Distribution
- US Distribution.
- Recall date
- December 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)