Sedecal recalled one mobile X-ray system on June 10, 2025, due to concerns about improper cleaning. The model SM-40HF-B-D-C is not water-resistant and poses risks if not cleaned according to instructions. Users must stop using the device 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 recalled product is the Model Number SM-40HF-B-D-C; 40KW CANON READY.005 Mobile X-ray system. It was distributed in California, Illinois, and New Jersey. The quantity recalled is one unit.
The mobile X-ray system is not water-resistant. Improper cleaning can lead to significant safety risks.
No injuries or incidents have been reported related to the recall. The product classification is Class II.
Stop using the device immediately. Follow the recall instructions provided by Sedecal. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0276-2026.
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