Z-1673-2026Class II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-08

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, Nige

Product quantity

298 units (27 US, 271 OUS)

Initiated by

Voluntary: Firm initiated

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.

Product description

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

Code / lot info

(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;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →