SEDECAL SA recalled 268 units of the 40KWFXPLUS Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly according to the manual. Healthcare facilities should stop using the device immediately and await further 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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The 40KWFXPLUS is a mobile X-ray imaging system used in hospitals and clinics to perform bedside radiographs.
The device is not water-resistant and requires cleaning per the manual. Improper cleaning can lead to damage or safety concerns as described by the manufacturer.
This recall is not indicated as part of a broader industry pattern.
Hospitals and clinics with the device must verify if they own an affected unit. 268 units are impacted across the US, with immediate cessation of use recommended until further instructions are provided.
Check the device label and data plate for model, serial number, and UDI/DI.
Not specified in the recall notice.
Retain recall notices, email communications, serials, and data plate photos. Log all handling steps and communications with the device vendor.
Model: 40KWFXPLUS UDI/DI: 08436046002166 Serial Numbers: G75176, G75504, G76697, G78126, G78025, G78715, G78307, G79071, G79091, G79193, G80165, G79928, G76507, G79861, G80255, G80202, G82594, G79057, G73017 Quantity: 268 units Distribution: United States (CA, IL, NJ) Sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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