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Moderate riskFDA DeviceClass II

Philips Azurion 3 M12 X-ray system recalled for intermittent foot switch failure

Philips identified a problem with the wired foot switch on certain Azurion 3 M12 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to work intermittently. About 298 systems worldwide are affected, including 27 in the U.S.

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

What to do

  1. Check if your system serial number matches the affected list on the FDA website
  2. Contact Philips Medical Systems for a replacement foot switch or repair instructions
  3. Do not use the affected foot switch until you receive guidance from Philips
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
298 units (27 US, 271 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1673-2026

In the FDA's words

Description
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; 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: 722063; UDI: 00884838085275; System Serial Number:122, 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145, 47, 146, 80, 102, 43, 117, 2, 149, 99, 44, 3, 28, 144, 62, 119, 61, 22, 29, 153, 40, 70, 30, 25, 19, 120, 121, 110, 14, 16, 17, 53, 103, 127, 97, 143, 41, 104, 116, 151, 93, 141, 115, 137, 73, 150, 128, 105, 4, 50, 129, 72, 38, 21, 78, 23, 76, 63, 69, 59, 51, 92, 139, 130, 154, 75, 24, 94, 100, 54, 46, 26, 71, 106, 83, 36, 37, 27, 15, 135, 123, 107, 87, 85, 89, 88, 86, 90, 91, 79, 133, 81, 140, 52, 48, 148, 55, 113; (2) System Code: 722221; UDI: 00884838085275; System Serial Number:181, 3, 7, 178, 54, 6, 93, 69, 9, 115, 177, 85, 19, 49, 171, 153, 108, 193, 104, 169, 45, 101, 135, 106, 51, 114, 36, 124, 197, 129, 4, 154, 146, 68, 195, 130, 183, 187, 42, 172, 164, 190, 151, 71, 152, 184, 147, 32, 105, 182, 58, 103, 149, 127, 128, 86, 122, 60, 155, 66, 33, 55, 70, 123, 118, 61, 44, 185, 74, 95, 205, 13, 99, 34, 142, 39, 144, 82, 145, 59, 77, 180, 126, 97, 132, 79, 91, 161, 102, 52, 120, 162, 64, 75, 41, 84, 131, 94, 96, 38, 48, 31, 92, 78, 186, 133, 167, 23, 26, 40, 10, 203, 30, 207, 208, 76, 50, 98, 107, 158, 157, 62, 29, 194, 73, 25, 15, 119, 140, 166, 57, 27, 2, 47, 16, 141, 143, 35, 168, 83, 163, 202, 67, 198, 134, 5, 81, 22, 28, 165, 196, 173, 46, 53, 8, 56, 174, 43, 159, 1, 176, 11; (3) System Code: 722229; UDI: 00884838085275; System Serial Number: 22, 9, 40, 7, 24, 35, 16, 15, 41, 5, 3, 29, 4, 38, 33, 32, 6, 2, 20, 26, 31, 10, 11, 21, 25, 13, 8; 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: 298 units (27 US, 271 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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