Sedecal recalled 24 units of its Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The equipment is not water-resistant and can lead to safety issues if not cleaned according to the manual. Healthcare providers and patients must stop using the device immediately.
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 involves the Sedecal Mobile X-ray system, with UDI/DI number 08436046002166 and multiple serial numbers including G30567 and G31256. The units were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to safety risks, as outlined in the manufacturer's manual.
No specific incidents have been reported. The recall is based on the potential hazards associated with improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by Sedecal and contact your healthcare provider.
For further instructions, contact SEDECAL SA directly or your healthcare provider. Additional information is available at the FDA's recall page.
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