SEDECAL SA recalled 1 unit of SM_40HF_BDC3 Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly per the manual. Healthcare facilities 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_BDC3 is a mobile X-ray system used in medical facilities for diagnostic imaging in patient rooms and emergency settings.
The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could create unsafe conditions or device malfunction.
This recall is not described as part of a broader industry pattern.
Facilities should halt use to prevent potential safety concerns. The recall could affect operational workflows and replacement timelines.
Recall notice and manufacturer instructions via FDA enforcement page and SEDECAL SA communications.
No timeline for remedy is stated.
Keep the recall notice, identifiers, provider communications, and any replacement agreements for records
Model numbers: UDI/DI 08436046001510; Serial numbers: G41213. Where sold: United States (California, Illinois, New Jersey). When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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