FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips ALLURA Xper FD10 X-ray system recalled for intermittent foot switch failure
OTHERNationwide distribution
Stop using Philips ALLURA Xper FD10 foot switch
Philips has identified a defect in the wired foot switch on certain ALLURA Xper FD10 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This could delay or disrupt imaging procedures. Philips is working with healthcare facilities to resolve the issue.
- If you operate or maintain an ALLURA Xper FD10 system, check your serial number against the affected units list
- Contact Philips Medical Systems for instructions on repair or replacement of the foot switch
- Do not rely solely on the wired foot switch until the issue is resolved; use alternative imaging initiation methods if available
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Sold states
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;
Affected count
2291 units (493 US, 1798 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1661-2026More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
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- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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