Sedecal recalled one Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The equipment is not water-resistant and can pose serious hazards if cleaned incorrectly. Users in California, Illinois, and New Jersey should stop using the device immediately.
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 product is the Mobile X-ray system, Model Number 40KW-FX.899. It was distributed in California, Illinois, and New Jersey. The unit is identified by UDI/DI 08436046002166 and Serial Number G72770.
The Mobile X-ray system is not water-resistant and requires strict adherence to cleaning instructions. Failure to clean according to the manual may lead to safety hazards.
No specific injuries or incidents have been reported related to this recall. However, the hazard level is classified as high.
Patients and healthcare providers should stop using the device immediately. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, contact SEDECAL SA via email. For additional resources, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0245-2026.
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