Sedecal SA recalled 1 unit of the SM_40HF_BDC Mobile X-ray System distributed in California, Illinois and New Jersey after notifying consignees that the unit is not water-resistant and must be cleaned strictly per the manual. The notice cites potential consequences of improper cleaning. Hospitals and providers should stop using the device 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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This is a mobile X-ray imaging system used in clinical settings to perform radiographic exams at patient bedsides or portable environments.
Water exposure or improper cleaning could compromise function or safety of the imaging system, potentially affecting performance.
This recall is not described as part of a broader industry pattern in the notice.
A single-unit recall with a high-hazard potential pending proper cleaning guidance; healthcare facilities should follow instructions to avoid equipment damage or unsafe operation.
Recall notice and FDA enforcement page. Manufacturer contact via SEDECAL SA.
Refund or replacement timelines are not specified in the notice.
Maintain copies of the recall notice, manufacturer instructions, and any corrective action taken by the facility.
Model numbers: UDI/DI 08436046001510; Serial Numbers: 31526. Distribution: United States (CA, IL, NJ). Sold from unknown date. Price: Unknown.
No injuries or incidents have been reported.
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