FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips Allura Xper FD20/10 X-ray system recalled for intermittent foot switch failure
What this means
Philips has identified a problem with the wired foot switch on certain Allura Xper FD20/10 X-ray systems that may prevent imaging from starting or cause it to work intermittently. This affects 85 systems worldwide, including 20 in the United States. No injuries have been reported.
- If your facility operates an affected Allura Xper FD20/10 system (System Code 722029), contact Philips Medical Systems for guidance
- Do not rely solely on the wired foot switch until you receive instructions from Philips
- Check the serial number list provided by Philips to determine if your system is affected
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
85 units (20 US, 65 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
Allura Xper FD20/10; System Code: 722029;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1668-2026More Philips recalls
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