FUJIFILM Healthcare Americas Corporation is recalling 16 units of the FDR Visionary Suite, model CH-200 X-ray system. The shaft used to mount the X-ray tube unit onto its support may break, and safety protective parts may not function correctly if a break occurs while the unit is being lifted or moved forward. Healthcare facilities should immediately stop using affected units and contact the manufacturer to arrange for a correction or repair.
If the mounting shaft breaks, the X-ray tube unit could fall or move unexpectedly, potentially striking patients or clinical staff. The failure of protective safety components during certain movements increases the risk of impact injuries during a structural failure.
Firm initiated voluntary recall for structural defect in X-ray tube mounting shaft.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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