Sedecal recalled nine units of its SM-40HF-Batt Mobile X-ray system on June 10, 2025, due to safety concerns. The equipment is not water-resistant and improper cleaning could lead to dangerous consequences. Patients and healthcare providers must stop using the device immediately.
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 SM-40HF-Batt Mobile X-ray system. Model numbers include UDI/DI 08436046001114 and serial numbers G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240. The devices were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning may lead to significant safety hazards.
No specific incidents or injuries have been reported related to this recall. The classification of the recall is Class II, indicating a high hazard level.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by Sedecal and contact the manufacturer for further guidance.
Contact SEDECAL SA or your healthcare provider for instructions. For more information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0261-2026.
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