Philips Medical Systems Nederland B.V. recalled 15 Allura Xper FD10C radiography systems worldwide, including 7 in the United States and 8 overseas. The devices may fail to initiate X-ray imaging or intermittently stop imaging when using the wired foot switch. Facilities should stop using the devices and await recall instructions from Philips.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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Product: Allura Xper FD10C X-ray imaging system. Model identifiers include System Code 722001 and associated serial numbers listed in the recall notice. Quantity recalled: 15 units (7 in the US, 8 outside the US). Distribution: Domestic nationwide and international across a long list of countries. Manufacturer: Philips Medical Systems Nederland B.V.
The risk is that X-ray imaging may not start or may intermittently fail during use when the wired foot switch is engaged. This could delay imaging and potentially affect patient diagnosis and care.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions issued by Philips and contact your healthcare provider for guidance. 3. Monitor for further recall communications. 4. Await the recall letter and any approved remedy.
Recall contact details are provided in the official recall materials and on the FDA enforcement page. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1659-2026. Phone numbers and hours are not listed in this notice.
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