Sedecal recalled 1 Mobile X-ray system due to major safety concerns. The device is not water-resistant and improper cleaning can cause malfunctions. Healthcare providers and patients must stop using the system immediately and follow manufacturer 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 SEDECAL Mobile X-ray system is used in healthcare settings for portable imaging. Medical professionals value this device for its mobility and efficiency in patient care.
The lack of water resistance means that liquids can enter sensitive internal components, causing electrical failures and potential patient safety issues if proper cleaning procedures are not followed.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the device immediately, which could disrupt medical services until a replacement or guidance is provided.
The serial number can typically be found on the back or underside of the device. Consult the user manual for exact locations.
4-6 weeks for refund processing from SEDECAL after following their instructions.
Keep all correspondences, receipts, and photos of the product to document your claims or issues.
Model Number: SM-40HF-B-D-C; UDI/DI: 08436046001510; Serial Numbers: G37587; Sold in: CA, IL, NJ; Recall Date: June 10, 2025.
No injuries or incidents have been reported.
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