FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips ALLURA Xper FD20 X-ray system recalled for foot switch malfunction
What this means
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 X-ray systems where imaging may not start or may start intermittently. This affects specific serial numbers across three system codes. No injuries have been reported.
- Check if your ALLURA Xper FD20 system serial number matches the recall list
- Contact Philips Medical Systems for instructions on the foot switch remedy
- Do not rely on the foot switch until you receive guidance from Philips
- Report any imaging failures or safety concerns to your device service representative
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
5084 units (1616 US, 3468 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1663-2026More Philips recalls
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