FDAJanuary 9, 2026device

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

fujifilm healthcare americasfujifilmfujifilm healthcare

UPCs

045402170522260454021705743604540217057450

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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