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.
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.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Fujifilm Medical Systems U.S.A., Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0232-2018 — Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM FDR Vi Hello, I own a Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR that is covered by recall Z-0232-2018 from Fujifilm Medical Systems U.S.A., Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
