Fdr Visionary Suite; Model Number: Ch-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FDR Visionary Suite Recall Summary The FDR Visionary Suite X-ray system (Model CH-200, versions 566-16130-23, 566-16130-31, and others) is being recalled because electromagnetic contacts inside the high-voltage generator cabinet can weld together, causing power to remain supplied to the circuit even when the device is turned off. This can lead to overheating, damage to surrounding components, and potential smoke generation. The recall affects users of this X-ray equipment manufactured by FUJIFILM Healthcare Americas Corporation.
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Product
- FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
- 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.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-09
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f71d6f0a-c233-429a-9736-173d9ad78cfb