FDR Visionary Suite recalled over fire hazard

Recall date

January 9, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-1299-2026

FDA classification

Class II

Brand / firm

FUJIFILM Healthcare Americas Corporation

Sold / distributed

US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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