SEDECAL SA recalled 1,198 units of its MobileDiagnost wDR 2.2 X-ray system on June 10, 2025. The equipment is not water-resistant and may pose hazards if not cleaned according to the manual. Users must stop using the device immediately and contact the manufacturer for further 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 MobileDiagnost wDR 2.2, Model Number REF 9890-010-89522, was distributed in California, Illinois, and New Jersey. The recall affects a total of 1,198 units.
The MobileDiagnost wDR 2.2 is not water-resistant. Improper cleaning can lead to serious equipment malfunction and possible injury.
No specific incidents have been reported. However, the potential for equipment failure due to improper cleaning poses a significant risk.
Stop using the device immediately. Follow the manufacturer's recall instructions and contact SEDECAL SA or your healthcare provider for guidance.
For further details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0243-2026 or contact SEDECAL SA.
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