SEDECAL SA recalled one unit of its SM-40HF-B-D-C Mobile X-ray system on June 10, 2025. The device poses a high hazard as it is not water-resistant and can lead to improper cleaning issues. Users must stop using the equipment immediately and follow the recall instructions sent via email.
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 recalled model is SM-40HF-B-D-C, UDI/DI 08436046001510, and Serial Number G33585. The device was distributed in California, Illinois, and New Jersey. It is classified as a Class II medical device.
The Mobile X-ray system is not water-resistant, which can lead to serious malfunctions if it comes into contact with moisture. Improper cleaning can jeopardize the device's functionality and safety.
There are no reported incidents or injuries related to this recall at this time. The manufacturer emphasizes the risk of improper cleaning.
Stop using the Mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions and to follow the recall process.
For more information, contact SEDECAL SA directly. Visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0266-2026.
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