Sedecal SA recalled 8 SM-32HF-B-D-C 32KW 50G Mobile X-ray systems sold in the US and Canada after notifying consignees by email that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines possible consequences of improper cleaning. Hospitals should stop using the devices immediately and follow the 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 SM-32HF-B-D-C is a 32KW 50G mobile X-ray system used in clinical settings for point-of-care radiography.
The recall notes the equipment is not water-resistant and must be cleaned per the manual. Improper cleaning could have consequences described by the manufacturer.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics in the US and Canada may need to halt use of affected devices until proper cleaning and recall procedures are followed.
Serial numbers and model information are typically on the device data plate or user manual.
Timelines for refunds or replacements are not specified in the provided recall notice.
Keep the recall notice, device serial numbers, model numbers, and all correspondence as records.
Model numbers: SM-32HF-B-D-C Distribution: US (CA, IL, NJ) and Canada Recall date: 2025-06-10 Quantity: 8 units Status: Active Brand: SEDECAL SA Note: Not water-resistant warning is in recall material.
No injuries or incidents have been reported.
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