SEDECAL SA recalled four units of its Mobile X-ray system on June 10, 2025, due to water-resistance issues. Improper cleaning can lead to serious safety hazards. Users must stop using the product immediately and follow 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 involves the Model Number SM-40HF-B-D-C; 40KW 55C/60C Mobile X-ray system. The affected units have UDI/DI 08436046001510 and serial numbers G35611, G37536, G37588, and G37490. The products were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant, posing risks if cleaned improperly. The manufacturer issued a reminder about following the cleaning instructions in the user manual.
There are no reported incidents of injury or death associated with this recall. The high hazard classification indicates potential for serious safety issues.
Stop using the Mobile X-ray system immediately. Follow the instructions provided by SEDECAL SA and consult your healthcare provider for next steps.
For further information, contact SEDECAL SA or refer to the recall notice at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0270-2026.
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