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Moderate riskFDA DeviceClass II

Philips ALLURA Xper FD20 OR Table recalled for intermittent X-ray foot switch failure

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.

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

What to do

  1. Check your system serial number against the affected list provided by Philips
  2. Contact Philips Medical Systems immediately if your table is affected
  3. Do not rely on the wired foot switch until the issue is resolved
  4. Follow Philips guidance for inspection, repair, or replacement of the foot switch
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 22 products — see all of them.

Details

Units affected
196 units (73 US, 223 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1665-2026

In the FDA's words

Description
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. (1) System Code: 722015; UDI: N/A; System Serial Number: 12, 16, 2, 8, 23, 3, 13; (2) System Code: 722023; UDI: 00884838059085; System Serial Number: 49, 41, 142, 110, 12, 179, 124, 27, 98, 66, 118, 117, 138, 42, 64, 116, 127, 175, 75, 82, 83, 46, 35, 109, 146, 33, 165, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 158, 5, 86, 34, 132, 9, 108, 121, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 87, 94, 57, 125, 73, 106, 67, 16, 96, 58, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150; (3) System Code: 722035; UDI: 00884838054240; System Serial Number: 119, 126, 169, 72, 124, 161, 183, 242, 245, 246, 46, 196, 52, 236, 147, 172, 123, 74, 59, 60, 88, 30, 216, 212, 85, 21, 47, 222, 121, 131, 145, 127, 38, 187, 243, 143, 244, 125, 117, 100, 57, 247, 34, 165, 252, 101, 89, 192, 111, 128, 227, 144, 174, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 83, 53, 32, 164, 56, 40, 10, 11, 62, 265, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 151, 92, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202; 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: 196 units (73 US, 223 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.

More from Philips

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