FDR Visionary Suite — Class II medical device recall Z-1898-2024
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2024-06-05, distributed nationwide. Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in
| Recall number | Z-1898-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FUJIFILM Healthcare Americas Corporation, Lexington, MA, United States |
| Recall initiated | 2024-04-11 |
| Classified | 2024-05-24 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| UPC / GTIN / UDI-DI | 04540217052226, 04540217057450 |
| Model numbers | 566-16130-23, 566-16130-33 |
Product
FDR Visionary Suite - 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. Model/Catalog Number: 566-16130-23 566-16130-33
Reason for recall
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
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-1898-2024. 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.