SEDECAL SA is recalling 845 units of the Sedecal X Optima URS digital mobile diagnostic x-ray system because certain parts can detach and fall off the equipment. This stationary unit, which features a universal swivel arm for taking x-ray exposures of patients in various positions, poses a safety risk to both patients and healthcare providers if components become loose or fall during use. Affected units include all serial numbers associated with UDI-DI 08436046002500, and users should contact the manufacturer immediately for instructions on inspections or repairs.
Parts of the equipment can unexpectedly fall off during operation, which may cause physical impact injuries to patients or medical staff or interfere with the safe positioning of the x-ray swivel arm.
Contact manufacturer for instructions
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.
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Sources: FDA iRES · Raw API Response
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