Sedecal SA recalled 1 mobile X-ray system in the United States. The device is distributed in CA, IL and NJ. The system is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could have unspecified consequences. Clinicians and facilities should stop using the device 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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This is a mobile X-ray imaging system used in clinical settings to perform radiographic exams at the point of care. The unit is designed for hospital or clinic use and is part of Sedecal’s medical imaging line.
The device is not water-resistant. Cleaning must follow the manual exactly. Improper cleaning can lead to damage or other safety concerns as described by the manufacturer.
This recall is not described as part of a broader industry pattern.
A single unit recall affects clinical workflows and requires immediate action to prevent potential equipment damage or safety issues related to cleaning procedures.
Look for the data plate on the device or consult Sedecal’s recall communications and the FDA recall page.
Remedies or replacements are communicated by Sedecal; processing timelines are not specified in the recall.
Keep copies of the recall notice, emails, and any responses from Sedecal SA. Save device identifiers (model, UDI, serial) for verification.
Model numbers: SM-40HF-B-D-C; 40KW CANON READY.005. Location: US distribution in CA, IL, NJ. Sold in the United States. UDI/DI: 08436046001510. Serial numbers: G36566. Quantity: 1 unit. Price: Unknown. Sold at: Unknown retail channels.
No injuries or incidents have been reported.
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