FDA DevicesClass II
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Published: April 8, 2026Recall ID: Z-1680-2026Category: devicesCountry: US
Reason for Recall / Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Product Description & Identification
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 98434 |
| Address 1 | Veenpluis 6 |
| Code info | (1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 481, 373, 149, 213, 45, 537, 615, 159, 18, 231, 180, 61, 204, 273, 538, 76, 502, 150, 132, 399, 533, 211, 17, 47, 38, 87, 617, 618, 619, 128, 522, 32, 600, 23, 25, 62, 177, 181, 48, 189, 153, 79, 80, 157, 24, 187, 26, 642, 431, 29, 113, 122, 127, 6, 123, 124, 185, 186, 198, 92, 215, 573, 91, 529, 523, 205, 20, 37, 659, 145, 3, 567, 539, 645, 156, 308, 333, 335, 570, 560, 44, 569, 418, 525, 280, 616, 387, 568, 471, 428, 465, 556, 629, 102, 103, 176, 178, 109, 16, 299, 234, 566, 508, 571, 463, 71, 493, 1, 434, 647, 317, 562, 230, 293, 552, 457, 458, 369, 561, 517, 203, 554, 260, 100, 101, 107, 108, 640, 99, 318, 21, 22, 676, 677, 154, 531, 75, 602, 78, 574, 158, 461, 370, 613, 393, 564, 482, 194, 660, 673, 60, 464, 4, 462, 138, 223, 312, 319, 98, 623, 475, 125, 218, 513, 442, 435, 9, 95, 557, 174, 548, 486, 487, 84, 454, 346, 396, 39, 339, 172, 191, 327, 52, 575, 196, 406... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 920 units (168 US, 752 OUS) |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionDomestic: 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;