Class II — FUJIFILM Healthcare Americas Corporation
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
|---|---|
| Registered facility | FUJIFILM Healthcare Americas Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) |
| Quantity | 16 units |
| Distribution | US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI. |
| Initiated | 2026-01-09 |
| Classified | 2026-02-05 |
| Recall number | Z-1299-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — FUJIFILM Healthcare Americas Corporation (Z-1299-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98124/
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