FDR Visionary Suite — Class II medical device recall Z-0044-2026
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2025-10-15, distributed in AK, CA, FL, IL, MA, NH, OH, WI. It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was fou
| Recall number | Z-0044-2026 |
|---|---|
| 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 | 2025-09-15 |
| Classified | 2025-10-07 |
| Reported by FDA | 2025-10-15 |
| Distributed | AK, CA, FL, IL, MA, NH, OH, WI |
| Quantity | 16 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04540217052226, 04540217057436, 04540217057450 |
| Serial numbers | MP95A8F5A001, MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, MP95AA783001, MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985002, MP95AA985003, MP95AA988001, MP95AA988002 |
Product
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Reason for recall
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
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-0044-2026. 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.