Sedecal SA recalled 5 SM-40HF-B-D-C Mobile X-ray systems distributed in California, Illinois and New Jersey after notifying consignees via email. The notice says the equipment is not water-resistant and must be cleaned strictly per the manual. Hospitals and clinics should stop using the devices immediately and follow the 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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Sedecal SA manufactures medical imaging equipment, including mobile X-ray systems used in hospitals and clinics to perform radiographic exams at the point of care.
The device is not water-resistant. Cleaning must follow the manual to avoid damage or exposure risks that could affect performance.
This recall highlights the importance of proper cleaning guidelines for delicate radiographic equipment and the potential risks when guidance is not followed.
Facilities must cease use immediately and follow recall steps. The impact is operational disruption and potential safety concerns if cleaning is not performed per the manual.
Device label for model, UDI/DI, and serial numbers. Recall notice from SEDECAL SA and FDA listing Z-0265-2026.
4-6 weeks for remedy processing is typical, but the recall notice does not specify a timeline.
Keep the recall notice, model numbers, UDI/DI, serial numbers, and all correspondence with the manufacturer.
Model numbers: SM-40HF-B-D-C; 40KW 55C Where sold: United States (California, Illinois, New Jersey) When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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