SEDECAL SA recalled 22 units of its Model SM-32HF-Batt Mobile X-ray system on June 10, 2025. The recall alerts users that the equipment is not water-resistant and requires strict cleaning per the manual. Improper cleaning may lead to serious safety risks.
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 Model SM-32HF-Batt, a 32KW analog Mobile X-ray system. It was distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Users must clean the device according to specific instructions to avoid risks associated with improper maintenance.
No specific incidents, injuries, or deaths have been reported related to this recall. The potential for issues arises from improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by SEDECAL SA and contact your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0256-2026.
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