Sedecal SA recalled 6 units of the SM-40HF-B-D-C 40KW Canon Ready Mobile X-ray System sold in California, Illinois and New Jersey. The company warned the equipment is not water-resistant and must be cleaned strictly per the manual to avoid possible consequences of improper cleaning. Users should stop using the device immediately and follow recall instructions provided by the manufacturer.
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 SM-40HF-B-D-C is a mobile X-ray system used in clinical settings to image patients at the point of care. It is designed for hospital use and requires regular cleaning per the manual.
The device is not water-resistant. Cleaning must adhere to the manual to prevent potential safety or performance issues.
This recall is not part of a broader industry pattern.
The impact is limited to six units. Hospitals and clinics with the affected devices should follow recall instructions to avoid risk.
Check the unit data plate and the manufacturer's recall notification. See FDA enforcement page linked in the recall.
Refunds or replacements typically take 4-8 weeks after submission, depending on the provider.
Keep the recall notice, serial numbers, photos of the data plate, correspondence with the manufacturer, and any maintenance records.
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system. Sold in the US: CA, IL, NJ. When sold: Unknown. Price: Unknown. UDI/DI: 08436046001510. Serial numbers include G-33126, G31259, G35641, G35630, G35718, G37357.
No injuries or incidents have been reported.
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