Sedecal recalled 12 units of its Mobile X-ray system on June 10, 2025. The equipment lacks water resistance and poses a high hazard if not cleaned properly. Users must follow strict cleaning protocols to avoid serious consequences.
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 recalled Mobile X-ray system is identified by model number 40KWFXPLUS-710CW. Twelve units were distributed across 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 failure and potential safety risks.
No incidents or injuries have been reported in relation to this recall. Improper cleaning could lead to significant equipment malfunction.
Stop using the Mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0251-2026 or contact SEDECAL SA directly.
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