Sedecal SA recalled 142 SM-40HF-B-D-C 40KW mobile X-ray systems sold to consignees in California, Illinois and New Jersey. Sedecal warned the units are not water-resistant and must be cleaned exactly as the manual prescribes, outlining the consequences of improper cleaning. Hospitals and clinics should stop using the devices immediately 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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Mobile X-ray systems are used in hospitals and clinics to perform bedside radiography, enabling imaging without transporting patients.
Not water-resistant and cleaning must follow the manual. Improper cleaning can cause damage or safety issues as described by the manufacturer.
This recall is not presented as part of a broader industry pattern.
142 units across CA, IL, NJ are affected. Facilities should halt use and follow manufacturer instructions to limit disruption and safety risk.
Recall notices and updates are posted on the FDA enforcement page and through Sedecal communications.
Recall resolution timelines vary; typical processing can take 4-8 weeks for instructions and disposition.
Keep the recall notice, email communications, serial numbers, UDI/DI details, and any correspondence with Sedecal SA for records
Model numbers: SM-40HF-B-D-C; 40KW, Mobile X-ray system. Sold to consignees in the United States (California, Illinois, New Jersey). When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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