Sedecal recalled 55 units of its Model Number 40KWFX Mobile X-ray system on June 10, 2025. The recall addresses the device's lack of water-resistance and improper cleaning risks. Users should 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
The recall affects 55 units of the Model Number 40KWFX Mobile X-ray system. The affected devices were distributed in California, Illinois, and New Jersey. The recall was initiated on June 10, 2025.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment malfunction and safety risks.
No specific incidents or injuries have been reported related to this recall. However, the manufacturer has highlighted the potential consequences of improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the cleaning instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, contact SEDECAL SA via email. Details can be found on the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0244-2026.
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