CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

Azurion 3 M12 recalled by Philips Medical Systems

Philips Medical Systems Nederland B.v is recalling Azurion 3 M12, distributed nationwide in the US. The recall was initiated on 3 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(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;

Quantity recalled298 units (27 US, 271 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1673-2026
FDA event ID: 98434
Recalling firm: Philips Medical Systems Nederland B.v, Best
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2026
FDA classified: 27 Mar 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Mar 2026	Recall initiated by company
27 Mar 2026	Classified by FDA	+24 days
8 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

Where it was distributed

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;

Nationwide Georgia

Questions about this recall

Is Azurion 3 M12 recalled?

Yes. Philips Medical Systems Nederland B.v recalled Azurion 3 M12 on 3 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1673-2026.

Why was it recalled?

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

Which lots are affected?

(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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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