SEDECAL SA recalled its Mobile X-ray system on June 10, 2025, due to cleaning safety concerns. The device is not water-resistant and improper cleaning may lead to serious consequences. Healthcare providers and patients 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 affected product is the SEDECAL RF.004 Mobile X-ray system. It is distributed in California, Illinois, and New Jersey. Specific serial numbers include 75723.
The Mobile X-ray system is not water-resistant. Improper cleaning can result in malfunction or safety risks.
There are no specific reported injuries or incidents linked to this recall. However, the potential for significant harm exists if the device is not properly maintained.
Stop using the Mobile X-ray system immediately. 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-0283-2026 or call SEDECAL SA.
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