Sedecal recalled one unit of its Mobile X-ray system on June 10, 2025. The equipment lacks water resistance and requires strict cleaning protocols. Users should stop using the device immediately to avoid potential hazards.
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 with model number UDI/DI 08436046001510 and serial number 31526. It was distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to malfunctions or safety risks.
There are no reported injuries or incidents associated with this recall. The company issued a precautionary reminder.
Stop using the device immediately. Follow the instructions provided by Sedecal SA and contact your healthcare provider for further guidance.
For more information, contact SEDECAL SA. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0286-2026.
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