FDASeptember 15, 2025device

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

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

The hazard

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

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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