Sedecal SA recalled a single SM-40HF-B-D-C 40KW mobile X-ray unit distributed to California, Illinois and New Jersey. The device is not water-resistant and must be cleaned per the manual, with explicit warnings about improper cleaning. Stop using the device and contact Sedecal SA or your healthcare provider for 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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A mobile X-ray system is used in hospitals and clinics to perform radiographic imaging at patient bedsides and other locations outside the fixed radiography room.
Not water-resistant. Cleaning must follow the manual. Improper cleaning could lead to damage or functional issues that affect safe operation.
This recall is not presented as part of a broader industry pattern in the provided information.
Facility downtime may occur as the unit is removed from service until guidance is provided.
Identifiers can be found on the device label near the control panel; UDI/DI and serial number are listed in the recall details.
Not specified by the recall; expect manufacturer instructions and possible service actions.
Keep a copy of the recall notice, note unit serials, and communications with Sedecal SA.
Model SM-40HF-B-D-C; 40KW 55C/60C; Distribution to CA, IL, NJ in the US. Recall date 2025-06-10. Status: Active. Quantity: 1 unit. Price: Unknown.
No injuries or incidents have been reported.
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