Sedecal SA recalls 1 unit of Model 40KWMOBILE3.899 Mobile X-ray system distributed to consignees in the United States, including California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly according to the manual, with the notice outlining the potential consequences of improper cleaning. Healthcare providers and patients should stop using the device immediat
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 perform imaging at patient bedsides or transport corridors. They enable rapid imaging in critical care or emergency settings and are essential for timely diagnoses.
The device is not water-resistant. Cleaning must follow the manual precisely. Improper cleaning could damage the device, potentially affecting imaging performance or electrical integrity.
This recall is not described as part of a broader industry pattern in the notice.
A single-unit recall with no injuries reduces immediate patient risk but could disrupt imaging services at facilities using the device until guidance is provided.
Refer to the FDA recall page linked in the notice for official identifiers and remedy steps.
Remedy processing timelines are not specified. Facilities should follow manufacturer guidance promptly.
Keep the recall notification, model and serial numbers, correspondence with Sedecal SA, and any service records related to the device.
Model numbers: 40KWMOBILE3.899. Sold in the United States to consignees in CA, IL, and NJ. Sold since: Distribution noted; recall date 2025-06-10. Original price: Unknown.
No injuries or incidents have been reported.
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