Philips Medical Systems Nederland B.V. recalled 5,084 ALLURA Xper FD20 imaging systems sold nationwide and internationally after finding that the wired foot switch may fail to initiate X-ray imaging or perform intermittently. The defect can delay or interrupt imaging during patient care. Healthcare facilities should stop using the devices 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 is a diagnostic radiology system used in clinical settings to perform X-ray imaging. It is part of Philips’ Allura line of interventional imaging products.
A failed or intermittent wired foot switch can prevent X-ray imaging from starting, delaying diagnosis or treatment during patient care.
This recall is not part of a broader industry pattern.
Facilities must halt use of affected devices until remediation. Delays in imaging can affect patient outcomes and workflow, with potential financial and operational consequences.
System labels, user manuals, and the recall notice; the FDA recall page lists the affected codes.
Remediation timelines vary by facility; expect several weeks for replacement or service arrangements.
Maintain copies of recall notices, correspondence with Philips, serial numbers, and service records.
Model numbers/Code: (1) System Code 722006, (2) 722012, (3) 722028. Where sold: Domestic nationwide and international list below. Sold since unspecified date. Price: Unknown. Quantity: 5084 units (1616 US, 3468 international). Country distribution includes Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, 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, El
No injuries or incidents have been reported.
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