Sedecal recalled 27 units of its Mobile X-ray system on June 10, 2025. The devices lack water resistance and require strict cleaning per the manual. Improper cleaning could lead to serious issues for users.
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
The recalled model is SM-40HF-B-D-C, a 40KW 50G Mobile X-ray system. It was distributed in California, Illinois, and New Jersey. The recall affects 27 units.
The Mobile X-ray system is not water-resistant. Users must adhere to specific cleaning instructions to avoid potential malfunction.
There are no reported injuries or incidents associated with this recall. However, improper cleaning can lead to serious operational hazards.
Stop using the Mobile X-ray system immediately. Follow the instructions provided in the recall email from Sedecal and consult your healthcare provider for further guidance.
Contact SEDECAL SA for more information regarding the recall. Additional details can be found on the FDA website.
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