SEDECAL SA recalled eight units of its Mobile X-ray system on June 10, 2025. The recall follows warnings regarding improper cleaning due to the device's lack of water resistance. Users must stop using the equipment immediately to avoid potential hazards.
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
Model Number: 40KWFXPLUS.002. Serial Numbers: G73508, G73512, G71323, G72419, G78910, G72425, G83214, G70934. Distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to device malfunction and potential safety risks.
No specific incidents or injuries have been reported related to this recall. The manufacturer issued this recall as a precautionary measure.
Stop using the Mobile X-ray system immediately. Follow the manufacturer's cleaning instructions and contact SEDECAL SA for further guidance.
For more information, contact SEDECAL SA or visit their website. Recall information is also available at the FDA's enforcement website.
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