SEDECAL SA recalled 6 units of its Mobile X-ray system on June 10, 2025. The equipment is not water-resistant and improper cleaning may lead to serious risks. Patients and healthcare providers 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
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The recalled Mobile X-ray system has model numbers SM-40HF-B-D-C and 40KW.005. The affected units were distributed in California, Illinois, and New Jersey. They were sold in an unknown price range.
The Mobile X-ray system is not water-resistant. Improper cleaning can result in significant risks to users and patients.
No specific incidents or injuries have been reported in association with this recall. The recall is classified as Class II due to the potential hazards.
Stop using the Mobile X-ray system immediately. Follow the instructions provided by SEDECAL SA. Contact your healthcare provider for further guidance.
For more information, contact SEDECAL SA or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0279-2026.
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