Sedecal SA recalls 6 units of the SM-40HF-B-D-C 40KW 80C Mobile X-ray system after warning consignees that the device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to safety risks. Hospitals and clinics in California, Illinois and New Jersey should stop using the device and follow the manufacturer's recall instructions.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
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The SM-40HF-B-D-C is a 40KW 80C mobile X-ray system used in clinical settings for point-of-care imaging.
Sedecal notes the device is not water-resistant. Cleaning must follow the manual to avoid damage or safety risks. Improper cleaning could compromise function or safety.
This recall is not part of a broader industry pattern.
Hospitals and clinics with the device should stop using it immediately to prevent potential safety risks. The recall affects 6 units in the US distributed to CA, IL, NJ.
Model plate on the device, UDI/DI label and serial number tags
Recall processing and potential replacement or guidance may take weeks; typical 4-8 weeks
Save the recall notice, emails, and any responses from Sedecal SA; photograph serial numbers, model numbers
Model numbers: SM-40HF-B-D-C; 40KW 80C; UDI/DI 08436046001510; Serial Numbers: G39822, G62662, G62564, G61702, G60067, G38060. Sold to consignees in the US, including California, Illinois, and New Jersey. Sold date: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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