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Moderate riskFDA DeviceClass II

Philips Allura Xper FD20/20 X-ray system recalled for foot switch imaging failure

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.

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

What to do

  1. Check if your system's serial number matches the affected list
  2. Contact Philips Medical Systems if your system is affected
  3. Do not rely solely on the wired foot switch until the issue is resolved
  4. Follow Philips instructions for inspection or replacement
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allura Xper FD20/20; System Code: 722038;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
111 units (31 US, 80 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1669-2026

In the FDA's words

Description
Allura Xper FD20/20; System Code: 722038; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. System Code: 722038; UDI: 00884838054226; System Serial Number: 71, 115, 42, 108, 173, 119, 60, 37, 38, 99, 130, 48, 157, 41, 141, 137, 49, 63, 35, 167, 55, 70, 39, 62, 46, 118, 67, 78, 120, 7, 106, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 122, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 170, 29; 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: 111 units (31 US, 80 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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