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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The Allura Xper FD20/20 is an interventional radiology X-ray imaging system used in hospitals to guide procedures.
A fault with the wired foot switch can prevent imaging from starting or cause intermittent imaging during procedures.
This recall is not described as part of a broader industry pattern.
Hospitals may experience delays or interruptions in imaging during patient procedures, potentially impacting clinical workflows and patient care.
Identifiers appear on the device label near the control panel and the model plate; the UDI is also listed in the recall documentation
Recall typically involves weeks to months for refunds or replacements, as communicated in the recall letter
Keep the recall letter, device labels showing System Code 722038 and UDI 00884838054226, purchase records, and all correspondence with Philips and hospital risk management
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.
No injuries or incidents have been reported.
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