Philips recalled 112 ALLURA Xper FD10/10 imaging systems nationwide in the United States and internationally after reports that X-ray imaging may not start or may intermittently stop when using the wired foot switch. The defect affects system codes 722005, 722011, and 722027. Healthcare providers should stop using the devices and follow Philips 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 FD10/10 is a diagnostic imaging system used in clinical settings to perform X-ray imaging. Hospitals and clinics purchase these systems to support interventional radiology and fluoroscopy workflows.
A malfunctioning wired foot switch can prevent X-ray imaging from starting or cause intermittent imaging during procedures. This may disrupt diagnostic or therapeutic workflows.
This recall is not described as part of a broader industry pattern.
The device failure can cause procedural delays and potential diagnostic inaccuracies, affecting patient care in busy radiology suites.
Manufacturer recall letters, FDA notice, device labels on the imaging system
Remediation timelines are not specified in the recall. Expect communications from Philips with next steps.
Keep recall communications, photos of device labels, serial numbers, purchase records, and correspondence with Philips or healthcare providers.
Product: ALLURA Xper FD10/10 imaging system System Codes: 722005, 722011, 722027 Quantity recalled: 112 units Distribution: Domestic nationwide in the United States; International distribution in 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, Colombia, Côte d’Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji,
No injuries or incidents have been reported.
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