Sedecal recalled its Mobile X-ray system, model 40KWFXPLUS.889, on June 10, 2025. The device is not water-resistant and improper cleaning can lead to serious issues. One unit distributed in California, Illinois, and New Jersey is affected.
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.889, a Mobile X-ray system. It was sold in California, Illinois, and New Jersey. The device has a unique device identifier of 08436046002166 and serial number G77146.
The Mobile X-ray system is not water-resistant. Improper cleaning may lead to electrical hazards, posing a significant risk to users.
No incidents or injuries have been reported related to this recall. However, the potential for serious consequences exists if cleaning instructions are not followed.
Users should stop using the device immediately. Follow the instructions provided by Sedecal and contact them or your healthcare provider for further guidance.
For more information, contact SEDECAL SA via email or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0250-2026.
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