SEDECAL SA recalled three Mobile X-ray systems on June 10, 2025, due to water resistance concerns. Users must strictly adhere to cleaning instructions to prevent potential hazards. 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
The recalled product is the SM_40HF_B_D_VIR3.004 Mobile X-ray system. The affected model numbers include UDI/DI 08436046002166 and serial numbers G73023, G87352, G80066. The systems were distributed in the US, specifically in California, Illinois, and New Jersey.
The Mobile X-ray systems are not water-resistant. Improper cleaning can lead to serious safety risks, including potential electrical hazards.
There have been no reported injuries or incidents related to the recalled units. The manufacturer issued this reminder to prevent potential hazards.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by SEDECAL SA or contact your healthcare provider for further guidance.
For more information, contact SEDECAL SA directly or visit their website. Further details can also be found at the FDA recall link.
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