SEDECAL SA recalled 1 unit SM-40HF-B-D-C 40KW 70C EN Mobile X-ray System after emailing consignees that the equipment is not water-resistant and must be cleaned per the manual. The notice outlines possible consequences of improper cleaning. Hospitals and providers should stop using the device immediately and follow the manufacturer’s 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-40HF-B-D-C is a mobile X-ray system used in clinical settings to perform radiographic imaging at patients’ bedsides or in clinics. Hospitals rely on these units for diagnostic imaging in various departments. The unit in question is a 40KW, 70C EN model.
The manufacturer notes the device is not water-resistant. Cleaning must be conducted per the manual. Improper cleaning could lead to safety or function issues.
This recall is not identified as part of a broader industry pattern in the notice.
The recall affects one unit in distribution to specific US states. Facilities must halt use and follow recall instructions to avoid potential safety or performance problems.
Look on the device label for model, UDI/DI, and serial numbers. The recall instructions were issued via email to consignees.
Further recall instructions from the manufacturer will specify steps and timelines.
Retain recall communications, device labels, serial numbers, and any responses from SEDECAL SA or healthcare providers.
Model SM-40HF-B-D-C; UDI/DI 08436046001510; Serial G62066. Distribution: US (CA, IL, NJ). Quantity: 1 unit. Sold in the US and Canada. Price: Unknown.
No injuries or incidents have been reported.
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