SEDECAL SA recalled 10 Mobile X-ray systems on June 10, 2025, due to a hazard related to improper cleaning. The equipment lacks water resistance, posing a risk to patients and healthcare providers. Users must stop using the device immediately and follow manufacturer 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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The recalled product is the Mobile X-ray system, Model Number SM-40HF-B-D-C. It was distributed in California, Illinois, and New Jersey.
The equipment is not water-resistant. Improper cleaning may lead to serious consequences, as outlined in the user manual.
No specific incidents have been reported as of now. The manufacturer issued this recall as a precautionary measure.
Stop using the device immediately. Follow the recall instructions provided by Sedecal and contact your healthcare provider for further guidance.
For more information, visit Sedecal's webpage or contact them directly via email. The recall details can also be found at the FDA website.
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