SEDECAL SA recalled five units of its Mobile X-ray system on June 10, 2025. The equipment poses a high hazard due to its lack of water resistance and improper cleaning risks. 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
The recall affects the Mobile X-ray system with model number SM-40HF-B-D-C. The UDI/DI is 08436046001510, and affected serial numbers include G35462, G-32753, G35480, G33111, and G33721. The devices distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant, which may lead to electrical hazards if not cleaned properly. Users must adhere strictly to cleaning instructions in the manual to avoid potential accidents.
No incidents have been reported yet. However, the high hazard classification indicates a significant risk associated with improper cleaning of the device.
Stop using the Mobile X-ray system immediately. Follow the instructions provided in the recall notification or contact SEDECAL SA or your healthcare provider for further guidance.
For more information, contact SEDECAL SA or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0265-2026.
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