Sedecal recalled six units of its mobile X-ray system on June 10, 2025. Users must stop using the device due to a risk of malfunction if not cleaned properly. The equipment is not water-resistant, which may lead to safety hazards.
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 recall affects the Model SM-40HF-B-D-C; 40KW - CANON READY Mobile X-ray system. Six units were distributed in California, Illinois, and New Jersey. The devices have serial numbers including G-33126 and G31259.
The mobile X-ray system is not water-resistant. Improper cleaning may lead to equipment malfunction, posing safety risks to patients and healthcare providers.
No incidents or injuries have been reported related to this recall. Users are advised to follow cleaning instructions closely to avoid potential hazards.
Stop using the mobile X-ray system immediately. Follow the recall instructions provided by Sedecal. Contact SEDECAL SA or your healthcare provider for further guidance.
For more information, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0257-2026. Users can also reach out to SEDECAL SA directly.
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