Philips Medical Systems Nederland B.V. recalls 111 Allura Xper FD20/20 imaging systems with System Code 722038. The recall covers 31 units in the United States and 80 abroad. The defect may prevent X-ray imaging from starting or cause intermittent imaging when using the wired foot switch. Stop using the device immediately and follow recall instructions from Philips or your healthcare provider.
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 FD20/20 imaging system. System Code: 722038. UDI: 00884838054226. System Serial Numbers: 71 and other listed identifiers (see model list). Quantity: 111 units (31 US, 80 outside the US). Sold nationwide in the United States and internationally in multiple countries. No price data provided.
There is a risk that X-ray imaging may not be initiated or may start intermittently when using the wired foot switch. This could affect diagnostic imaging during patient care.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Philips. 3. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. 4. Monitor for recall updates and letters from the manufacturer. 5. Await further guidance on refunds or replacements.
Recall notice indicates notification by letter. Direct contact information not provided in the summary. FDA page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1669-2026.
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