SEDECAL SA recalled 7 units of its Mobile X-ray system on June 10, 2025. The devices may pose a water hazard due to improper cleaning. Healthcare providers must stop using this device immediately and follow the recall 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
The recalled Mobile X-ray system is model number 40KWFXPLUS-710CW.007. The devices were distributed in California, Illinois, and New Jersey. The specific serial numbers include G79192, G79195, G79212, G78205, G80256, G79692, and G80053.
The Mobile X-ray system is not water-resistant, which may lead to malfunction or electrical hazards if not cleaned according to the manufacturer's instructions. Users must follow the cleaning protocols outlined in the manual.
There are no reported injuries or incidents associated with this recall. Users are advised to adhere strictly to cleaning instructions to prevent potential hazards.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by SEDECAL SA. Contact the manufacturer or your healthcare provider for further guidance.
For more information, visit the SEDECAL SA website or email them directly. Additional details are available at the FDA's recall page.
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