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Moderate riskFDA DeviceClass II

Philips Allura Xper FD10C X-ray system recalled for foot switch imaging malfunction

Philips has identified a problem with the wired foot switch on certain Allura Xper FD10C X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start intermittently, which could affect clinical workflow. This affects a small number of systems worldwide.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If you operate an Allura Xper FD10C system, contact Philips Medical Systems for guidance on your specific unit
  2. Check if your system's serial number matches the affected list and verify the issue with your equipment
  3. Follow any instructions or updates provided by Philips for repair or remediation
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allura Xper FD10C; System Code: 722001;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
15 units (7 US, 8 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1659-2026

In the FDA's words

Description
Allura Xper FD10C; System Code: 722001; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. System Code: 722001; UDI: N/A; System Serial Number: 19, 249, 21, 18661014, 77, 82, 195, 216, 337, 37, 258, 283, 15, 256, 305; Distribution: 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 quantity: 15 units (7 US, 8 OUS)
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

22 products in this recall

Philips X-ray systems recalled for faulty foot switch

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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