FUJIFILM FDR Visionary Suite with CH-200 — Class II medical device recall Z-0232-2018
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2017-12-20. A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR V
| Recall number | Z-0232-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, United States |
| Recall initiated | 2017-06-15 |
| Classified | 2017-12-10 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2018-05-09 |
| Quantity | 3 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04540217052226 |
| Model numbers | CH-200 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0232-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.