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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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
The wired foot switch may fail to start X-ray imaging or may do so intermittently during procedures. The result is potential delays or interruptions during imaging tests and interventions.
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) Await further guidance from the recall notice.
Notification method: Letter. Brand: Philips Medical Systems Nederland B.V. For direct questions, contact the manufacturer or your healthcare facility. FDA notice provides recall details at the linked enforcement page.
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