SEDECAL SA recalled one unit of its Mobile X-ray system on June 10, 2025. The device is not water-resistant and requires strict cleaning per the manual. Improper cleaning may lead to serious safety risks for patients and healthcare providers.
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 product is the Mobile X-ray system, model number 40KWMOBILE3.899. The device was distributed in California, Illinois, and New Jersey. One unit was recalled.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to electrical hazards and malfunctions.
No specific incidents or injuries have been reported related to this recall. The potential for danger exists if the cleaning instructions are not followed.
Stop using the Mobile X-ray system immediately. Follow the manufacturer’s instructions for return or disposal. Contact SEDECAL SA or your healthcare provider for further guidance.
For further information, contact SEDECAL SA via email or visit their website at www.sedecal.com. More details are also available on the FDA's website.
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