Sedecal recalled 2 units of the SM-40HF-B-D-C 40KW 55G/60G Mobile X-ray system after warning consignees that the device is not water-resistant and must be cleaned exactly according to the manual. The notice outlines the potential consequences of improper cleaning. Healthcare facilities in California, Illinois and New Jersey should stop using the device immediately and contact Sedecal for further 1
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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Mobile X-ray systems are used in hospitals and clinics to image patients at the point of care. They require regular cleaning and maintenance per manufacturer instructions to ensure patient safety and device reliability.
The device is not water-resistant, so improper cleaning could lead to potential safety or equipment integrity issues as outlined by the manual. This creates a high-risk scenario for users who fail to follow cleaning protocols.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to adjust cleaning procedures and monitor this equipment closely while awaiting remediation guidance.
Identifiers are on the equipment label and in the serial plate. The manual also lists cleaning requirements.
Remedies and replacements, if offered, typically take several weeks to complete.
Keep a copy of the recall notice and all correspondence with Sedecal SA. Photograph serial numbers and model labels.
Model numbers: SM-40HF-B-D-C; 40KW 55G/60G Sold to consignees in the United States (CA, IL, NJ) When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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