Sedecal SA recalled 12 mobile X-ray systems in the United States, including units distributed to California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned strictly per the manual to avoid safety risks. Stop using the device immediately and follow the manufacturer’s recall 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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This is a mobile X-ray system used in hospitals and clinics to perform bedside radiography and imaging. It is designed for use in patient care environments.
The device is not water-resistant. Cleaning must follow the manual. Improper cleaning could cause device damage or safety risks for patients and operators.
This recall is not described as part of a broader industry pattern.
Facilities with affected units must stop use and follow manufacturer instructions. The recall affects 12 units across CA, IL, and NJ. No injuries reported yet.
FDA recall page Z-0249-2026 and Sedecal communications. Unit identifiers include UDI/DI 08436046002166 and serials like G82576, G82871, G72391, etc.
No timeline is provided for refunds or replacements. Follow Sedecal instructions for next steps.
Keep recall notices, emails, serial numbers, model numbers, and all correspondence with Sedecal and providers for records.
Model: 40KWFXPLUS.005. Location: United States (CA, IL, NJ). Recall date: 2025-06-10. Price: Unknown.
No injuries or incidents have been reported.
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