SEDECAL SA recalled one Mobile X-ray system on June 10, 2025, after warning that improper cleaning could lead to equipment failure. The device is not water-resistant and must be cleaned according to strict manual instructions. The recall affects units distributed in California, Illinois, and New Jersey.
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 with model number SM-40HF-B-D-C and UDI/DI 08436046001510. It was distributed in California, Illinois, and New Jersey. One unit is affected in this recall.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment failure, posing a risk to patient safety.
No specific incidents of injury or death have been reported related to this recall. However, the hazard level is classified as high due to the potential consequences of improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the instructions provided by SEDECAL SA for returning the device or seeking further guidance.
For further assistance, contact SEDECAL SA or your healthcare provider. Visit the FDA recall page at the provided URL for more details.
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