SEDECAL SA recalled one Mobile X-ray system on June 10, 2025, due to a lack of water resistance. Improper cleaning can lead to serious hazards. Users must stop using the device immediately and follow the manufacturer’s 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
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The recalled product is the SM_40HF_BDC3 Mobile X-ray system, identified by model UDI/DI 08436046001510 and serial number G41213. It was distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning can result in equipment malfunction or failure.
There are no reported incidents or injuries associated with this recall. This recall is preventive based on the potential risks of improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the cleaning instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, visit the SEDECAL website or contact their customer service via email as per the notification.
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