Recall Z-1679-2026
Philips Medical Systems Nederland B.V. · initiated March 3, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Azurion 5 M12; System Code: (1)722227, (2)722231;
Codes / lots: (1) System Code: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192, 156, 250, 98, 31, 128, 81, 24, 37, 320, 179, 270, 151, 53, 246, 245, 84, 38, 28, 29, 170, 30, 338, 324, 108, 305, 168, 172, 356, 346, 62, 236, 25, 313, 339, 104, 321, 59, 109, 101, 19, 155, 99, 285, 247, 261, 298, 177, 138, 337, 157, 158, 228, 249, 61, 287, 55, 239, 306, 215, 336, 213, 76, 216, 73, 318, 353, 65, 167, 41, 85, 191, 20, 226, 102, 40, 87, 163, 83, 251, 268, 309, 310, 316, 290, 272, 5, 6, 7, 218, 36, 75, 195, 43, 345, 116, 18, 153, 351, 352, 14, 15, 120, 262, 204, 258, 326, 348, 17, 141, 114, 103, 355, 113, 110, 315, 21, 161, 194, 105, 173, 174, 64, 49, 71, 91, 187, 166, 210, 219, 222, 273, 205, 280, 300, 256, 335, 121, 80, 123, 243, 344, 308, 22, 140, 90, 142, 69, 200, 72, 362, 242, 323, 331, 136, 269, 137, 77, 89, 294, 181, 234, 95, 2, 111, 221, 293, 165, 342, 1, 12, 16, 257, 330, 67, 340, 260, 148, 281, 284, 248, 333, 199, 183, 106, 253, 145, 164, 241, 52, 26, 233, 301, 211, 154, 217, 332, 334, 44, 198, 297, 206, 292, 130, 58, 203, 47, 48, 107, 93, 125, 240, 122, 118, 112, 46, 176, 92, 252, 184, 57, 202, 100, 115…
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.
FDA-determined cause: Device Design
Action taken
On March 3, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 6. Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken.
Details
- Recall number
- Z-1679-2026
- Initiated
- March 3, 2026
- Posted by FDA
- March 27, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 345 units (10 US, 335 OUS)
- 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…
- Recalling firm
- Philips Medical Systems Nederland B.V., Best
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1659-2026 Class II | Allura Xper FD10C; System Code: 722001;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1660-2026 Class II | ALLURA Xper FD10F; System Code: 722002;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1661-2026 Class II | ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1662-2026 Class II | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1663-2026 Class II | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1664-2026 Class II | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1665-2026 Class II | 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… | 03/03/2026Open, Classified |
| Z-1666-2026 Class II | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1667-2026 Class II | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1668-2026 Class II | Allura Xper FD20/10; System Code: 722029;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1669-2026 Class II | Allura Xper FD20/20; System Code: 722038;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1670-2026 Class II | Allura Xper FD20/20 OR Table; System Code: 722039;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1671-2026 Class II | Allura Xper FD20/15; System Code: 722058;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1672-2026 Class II | Allura Xper FD20/15 OR Table; System Code: 722059;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1673-2026 Class II | 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… | 03/03/2026Open, Classified |
| Z-1674-2026 Class II | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1675-2026 Class II | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1676-2026 Class II | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1677-2026 Class II | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1678-2026 Class II | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |
| Z-1680-2026 Class II | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when… | 03/03/2026Open, Classified |