SEDECAL SA recalled one unit of its mobile X-ray system on June 10, 2025. The system is not water-resistant and poses a high hazard risk due to improper cleaning. Users must stop using the 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
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The recalled product is the Model Number SM-20HF-Batt; 20KW ANALOG Mobile X-ray system. The device was distributed to California, Illinois, and New Jersey. It has model identifiers UDI/DI 08436046001091 and serial number G23218.
The mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment failure and potential harm to patients.
There have been no reported incidents or injuries associated with this recall. The potential for risk remains high due to improper cleaning.
Stop using the mobile X-ray system immediately. Follow the cleaning instructions provided in the manual to avoid hazards.
For further instructions, contact SEDECAL SA or your healthcare provider. Visit the FDA recall page for more information.
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