FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips ALLURA Xper FD10/10 X-ray system recalled for foot switch imaging failure
What this means
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10/10 X-ray systems where imaging may not start or may work on and off intermittently. This affects 112 systems distributed worldwide, identified by specific serial numbers.
- Locate your system's serial number and check if it matches the affected list provided by Philips
- Contact Philips Medical Systems if your system is listed
- Follow Philips instructions for inspection or repair of the foot switch
The agency's original wording
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Intended for
Adults
Illnesses reported
None reported
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
112 units (138 US, 422 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1662-2026More Philips recalls
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