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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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
Philips identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. This could affect imaging workflows and patient care.
No injuries or incidents have been reported.
1. Stop using the product. 2. Disconnect from power and follow facility protocols for device recall. 3. Review the official recall notice from Philips and the FDA page cited in this article. 4. Contact Philips Medical Systems Nederland B.V. for instructions regarding remediation. 5. For instructions and remediation details, refer to the recall notice on the FDA enforcement page linked in this article.
Phone: Unknown. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1663-2026. Hours: Unknown.
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