Sedecal SA recalls 181 SM-40HF-B-D-C mobile X-ray systems in 2025 after concerns about cleaning and water resistance. The device is not water-resistant and must be cleaned strictly according to the manual. Manufacturers warn of potential consequences if cleaning is not followed. Hospitals and clinics should stop using the device and follow recall instructions 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
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The SM-40HF-B-D-C is a mobile X-ray system used in hospitals and clinics for portable imaging. It operates at 40KW and 70C, designed for on-site radiography.
The device is not water-resistant. Cleaning must follow the manual to avoid adverse conditions. Improper cleaning could compromise safety or equipment integrity.
This recall is not stated as part of a broader industry pattern.
Facilities must stop using the unit until instructions are provided. Image acquisition and patient flow could be disrupted while awaiting remediation.
Device labels show model, UDI/DI, and serial numbers. Official recall details are on the FDA enforcement page linked in the notice.
Remedy timeline not specified in the notice. Expect manufacturer guidance and FDA updates.
Keep copy of the recall notice, emails, and communication with Sedecal SA. Log serial numbers, UDI, and device condition before and after remediation.
Model: SM-40HF-B-D-C; 40KW 70C mobile X-ray system. Quantity: 181 units. Distribution: United States in CA, IL, and NJ. UDI/DI: 08436046001510. Serial Numbers include D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892. Sold/price: not disclosed.
No injuries or incidents have been reported.
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