Recall
FDAHealthMarch 3, 2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — ALLURA Xper FD10F; System Code: 722002;

⚠️ Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 3, 2026

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;

What's affected?

Product
ALLURA Xper FD10F; System Code: 722002;
Lot code
System Code: 722002; UDI: N/A; System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40;

Additional details

System Code: 722002; UDI: N/A; System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 10 units (8 US, 2 OUS).

View original FDA notice →

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