Philips recalled 85 Allura Xper FD20/10 imaging systems distributed nationwide and internationally. The devices may fail to initiate X-ray imaging or do so intermittently when using the wired foot switch. Hospitals and clinicians should stop using the device and follow the manufacturer’s recall instructions.
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 FD20/10 is an interventional radiology fluoroscopy system used in hospitals for real-time X-ray imaging during procedures.
A wiring foot switch may fail to initiate X-ray imaging or operate intermittently, potentially disrupting procedures and imaging continuity.
This recall is not presented as part of a broader industry-wide pattern in the provided data.
Hospitals may experience imaging delays or interruptions during procedures, affecting workflow and patient care.
Recalls are published on the FDA enforcement page and through Philips communications to healthcare facilities.
Philips will coordinate remediation with facilities; timelines vary by site.
Keep the recall letter, correspondence with Philips, service orders, and incident reports related to the device.
Model/Identification: System Code 722029; UDI 00884838059078; System Serial Number 57. Quantity: 85 units (20 US, 65 outside the US). Distribution: Domestic nationwide; Internationally to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Côte d’Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, 2
No injuries or incidents have been reported.
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