SEDECAL SA recalled five units of its Mobile X-ray system on June 10, 2025. The device is not water-resistant, posing a risk if not cleaned properly. Users must follow strict cleaning guidelines to avoid serious consequences.
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 recall involves model number SM-40HF-B-D-C; 40KW 55G Mobile X-ray system. The affected units were distributed in California, Illinois, and New Jersey. The recall applies to five units in total.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment malfunction, posing risks to patient safety.
There are no reported incidents or injuries associated with this recall. Users should remain cautious and adhere to cleaning instructions.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by the manufacturer and contact SEDECAL SA or your healthcare provider for further guidance.
For more information, contact SEDECAL SA via email or visit their website. Additional details are available at the FDA recall page.
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