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