Z-1674-2026Class II
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only)
Philips Medical Systems Nederland B.V. / initiated 2026-03-03 / Open, Classified / root cause: design
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only) on . FDA classified it as Class II and gives the reason as "Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1674-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Product
- Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
- Product code
- OWB Interventional Fluoroscopic X-Ray System
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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.
- Quantity in commerce
- 798 units (42 US, 756 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 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;
- Product codes and lots
- (1) System Code: 722064; UDI: 00884838085282; System Serial Number: 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169, 297, 131, 479, 190, 268, 173, 220, 256, 290, 502, 425, 412, 89, 303, 130, 157, 60, 263, 264, 253, 254, 257, 280, 373, 417, 9, 277, 102, 467, 461, 137, 46, 101, 84, 510, 5, 78, 49, 345, 180, 185, 266, 271, 193, 212, 213, 214, 431, 250, 186, 246, 282, 354, 374, 274, 127, 451, 106, 490, 329, 276, 58, 81, 200, 179, 249, 156, 184, 6, 448, 10, 82, 323, 35, 69, 278, 511, 39, 40, 45, 66, 125, 484, 36, 94, 497, 104, 422, 132, 67, 183, 439, 70, 446, 50, 138, 292, 293, 321, 379, 151, 237, 519, 520, 208, 462, 342, 57, 222, 391, 98, 441, 320, 494, 79, 65, 87, 109, 75, 311, 442, 485, 121, 68, 384, 228, 252, 91, 73, 74, 124, 191, 122, 421, 119, 309, 400, 251, 468, 480, 387, 269, 111, 11, 147, 509, 454, 478, 262, 491, 133, 337, 275, 414, 405, 396, 247, 310, 406, 517, 432, 457, 426, 304, 469, 340, 393, 343, 458, 322, 444, 508, 445, 395, 385, 505, 472, 514, 333, 236, 471, 234, 503, 394, 407, 470, 498, 504, 413, 7, 440, 463, 330, 475, 473, 501, 308, 225, 483, 474, 344, 389, 492, 324, 265, 235, 120, 496, 427, 341, 287, 288, 289, 380, 149, 150, 176, 197, 230, 231, 233, 44, 100, 51, 388, 118, 62, 123, 177, 47, 272, 110, 59, 167, 174, 165, 401, 452, 41, 168, 447, 148, 182, 112, 302, 86, 317, 198, 378, 206, 136, 312, 143, 403, 386, 397, 500, 226, 408, 43, 381, 488, 443, 416, 80, 12, 404, 285, 515, 476, 449, 477, 338, 419, 215, 164, 434, 114, 144, 327, 227, 295, 294, 319, 241, 126, 92, 284, 175, 199, 372, 188, 429, 296, 172, 283, 357, 306, 437, 210, 315, 134, 255, 207, 192, 116, 221, 189, 117, 313, 187, 166, 96, 135, 108, 37, 245, 72; (2) System Code: 722222; UDI: 00884838099210; System Serial Number: 332, 111, 254, 256, 257, 265, 255, 100, 99, 310, 69, 12, 226, 15, 19, 23, 17, 55, 45, 187, 223, 358, 112, 113, 367, 120, 356, 262, 37, 318, 152, 364, 146, 246, 269, 75, 304, 316, 174, 230, 307, 320, 336, 338, 339, 340, 343, 344, 345, 346, 362, 308, 182, 27, 56, 312, 368, 172, 137, 302, 328, 35, 383, 96, 382, 151, 138, 384, 363, 224, 386, 395, 102, 118, 119, 145, 209, 210, 331, 351, 372, 373, 361, 88, 89, 108, 132, 48, 53, 4, 305, 80, 83, 47, 270, 21, 64, 22, 98, 29, 248, 266, 378, 245, 18, 24, 335, 177, 11, 72, 244, 9, 66, 50, 263, 65, 278, 82, 188, 68, 51, 5, 76, 243, 139, 319, 31, 193, 106, 392, 287, 178, 117, 267, 92, 324, 213, 281, 229, 215, 300, 268, 104, 353, 141, 133, 142, 105, 250, 251, 252, 253, 183, 375, 311, 228, 322, 189, 297, 190, 313, 169, 219, 247, 282, 217, 143, 349, 225, 162, 333, 185, 166, 161, 369, 134, 222, 389, 370, 374, 396, 399, 280, 249, 115, 321, 211, 168, 127, 261, 54, 14, 38, 10, 67, 165, 272, 326, 173, 90, 109, 13, 288, 289, 290, 291, 294, 295, 292, 186, 181, 107, 379, 385, 296, 314, 315, 390, 77, 354, 380, 110, 184, 180, 131, 284, 376, 366, 214, 116, 276, 73, 365, 398, 157, 87, 114, 274, 135, 159, 158, 78, 125, 218, 124, 126, 192, 212, 149; (3) System Code: 722230; UDI: 00884838116733; System Serial Number: 40, 2, 22, 10, 50, 4, 5, 19, 20, 23, 25, 30, 41, 67, 7, 45, 15, 28, 60, 38, 9, 62, 63, 57, 58, 54, 55, 39, 27, 52, 13, 12, 1, 68; (4) System Code: 722280; UDI: 00884838103276; System Serial Number: 57, 161, 43, 179, 229, 249, 65, 76, 232, 113, 167, 165, 80, 128, 158, 149, 194, 44, 100, 164, 240, 246, 66, 135, 175, 99, 112, 34, 79, 130, 48, 52, 141, 131, 142, 143, 144, 189, 37, 83, 223, 139, 87, 61, 259, 218, 90, 188, 105, 23, 30, 132, 96, 107, 171, 118, 21, 174, 220, 147, 133, 264, 38, 243, 177, 178, 150, 69, 148, 210, 207, 98, 211, 127, 222, 198, 71, 146, 241, 206, 152, 262, 157, 40, 17, 204, 260, 187, 208, 46, 235, 234, 91, 97, 153, 245, 106, 173, 258, 120, 45, 92, 226, 254, 213, 224, 95, 54, 126, 216, 19, 271, 215, 93, 24, 129, 74, 219, 88, 85, 86, 170, 55, 102, 123, 124, 125, 151, 39, 47, 101, 209, 41, 42, 53, 250, 239, 248, 108, 119, 205, 197, 82, 33, 20, 231, 63, 261, 138, 255, 212, 84, 221, 36, 247, 256, 59, 196, 50, 110, 199, 140, 68, 117, 49, 257, 60, 103, 237, 72, 160, 81, 114, 137, 58, 73, 35, 22, 94;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1659-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1660-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1661-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1662-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1663-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1664-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1665-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1666-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1667-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1668-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1669-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1670-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1671-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1672-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1673-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1674-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1675-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1676-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1677-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1678-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1679-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1680-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.