FDA-Device2026-04-08Class IIPROCESSING DEFECT
Philips ALLURA Xper FD20 OR Table recalled for intermittent X-ray foot switch failure
What this means
Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 surgical X-ray tables. The switch may fail to start X-ray imaging or may cause imaging to work only intermittently, which could disrupt surgical procedures. This affects 196 units worldwide.
- Check your system serial number against the affected list provided by Philips
- Contact Philips Medical Systems immediately if your table is affected
- Do not rely on the wired foot switch until the issue is resolved
- Follow Philips guidance for inspection, repair, or replacement 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
196 units (73 US, 223 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1665-2026More Philips recalls
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