FDR Visionary Suite — Class II medical device recall Z-1299-2026
Ongoing recall by FUJIFILM Healthcare Americas Corporation, reported 2026-02-11, distributed nationwide. It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-vol
| Recall number | Z-1299-2026 |
|---|---|
| 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 | 2026-01-09 |
| Classified | 2026-02-05 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04540217052226, 04540217057436, 04540217057450 |
| Serial numbers | MP95A9F6A001, MP95A9F6B001, MP95A9F74001, MP95A9F74002, MP95A9F76001, MP95A9F78001, MP95AA783001, MP95AA983001, MP95AA983002, MP95AA983003, MP95AA985001, MP95AA985002, MP95AA985003, MP95AA988001, MP95AA988002 |
| Model numbers | CH-200 |
Product
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Reason for recall
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
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-1299-2026. 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.