FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips Allura Xper FD20/20 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 FD20/20 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to work only intermittently, which could affect clinical procedures.
- Check if your system's serial number matches the affected list
- Contact Philips Medical Systems if your system is affected
- Do not rely solely on the wired foot switch until the issue is resolved
- Follow Philips instructions for inspection or replacement
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
111 units (31 US, 80 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
Allura Xper FD20/20; System Code: 722038;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1669-2026More Philips recalls
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