SEDECAL SA recalled 268 units of the Model Number 40KWFXPLUS Mobile X-ray system on June 10, 2025. The recall addresses concerns over improper cleaning and water resistance. Healthcare providers must stop using the device immediately and follow the manufacturer’s 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 Model Number 40KWFXPLUS Mobile X-ray system is recalled. It was distributed in California, Illinois, and New Jersey. The recall affects 268 units.
The Mobile X-ray system is not water-resistant. Improper cleaning may lead to equipment failure or unsafe conditions for patients.
No specific incidents or injuries have been reported related to this recall. The manufacturer issued the recall as a precaution.
Stop using the Mobile X-ray system. Contact SEDECAL SA or your healthcare provider for further instructions on the recall.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0246-2026.
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