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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- FDASiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay2026-05-07
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