SEDECAL SA recalled four units of its Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The manufacturer warns the equipment is not water-resistant and requires strict adherence to cleaning instructions. Users must stop using the device immediately and follow recall instructions for safety.
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 product is the Model Number SM-40HF-B-D-C; 40KW 50C Mobile X-ray system. It was distributed in California, Illinois, and New Jersey. The recall affects four units.
The Mobile X-ray system is not water-resistant, posing risks if it is improperly cleaned. Users must adhere strictly to the cleaning instructions in the manual to avoid potential hazards.
There are no reported incidents or injuries associated with this recall at this time. Users are encouraged to follow the manufacturer's cleaning instructions.
Stop using the Mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions regarding the recall.
For more information, visit SEDECAL SA's website or contact them directly. Additional details are available at the FDA's recall page.
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