Sedecal recalled three Mobile X-ray systems on June 10, 2025, after warning users about improper cleaning risks. The equipment is not water-resistant and can pose dangers if not maintained according to the manual. This recall affects units distributed in California, Illinois, and New Jersey.
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 involves Model Number 40KWFXPLUS.004 Mobile X-ray systems. Three units are affected, identified by serial numbers G84489, G84504, and G84589. The devices were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant and improper cleaning can lead to malfunction or safety hazards. Users must adhere strictly to the cleaning instructions outlined in the manual to avoid potential risks.
No injuries or incidents have been reported at this time. The manufacturer issued the recall proactively to mitigate any potential risks.
Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions and contact SEDECAL SA or your healthcare provider for further guidance.
For more information, contact SEDECAL SA. Visit the FDA's website for recall details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0248-2026.
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