Sedecal recalled the Sed URS LP Mobile X-ray System in the United States, including CA, IL and NJ. The device is not water-resistant and must be cleaned strictly per the manual. Hospitals and healthcare providers should stop using the device immediately and follow Sedecal'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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Mobile X-ray systems are used in hospitals for bedside imaging, enabling rapid assessment without transport. They are critical equipment in emergency and inpatient care.
The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could lead to damage or safety risks in a clinical setting.
This recall is not part of a broader industry pattern.
Hospitals in CA, IL, and NJ may need to pause certain imaging workflows and coordinate with the manufacturer for replacement or remediation; the recall is active.
Recall notice and FDA enforcement page linked in the article; manufacturer contact for Sedecal SA instructions
Remediation timeline varies by institution; manufacturers typically coordinate replacements or service, potentially weeks.
Keep a log of serial numbers checked, communications with the manufacturer, and remediation steps taken
Model numbers: Serial Numbers 40116; UDI/DI unknown. Sold in the United States in CA, IL, NJ. Sold date and price not disclosed.
No injuries or incidents have been reported.
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