Azurion 5 M12; System Code: (1)722227, (2)722231;
Class I - DangerousWhat Should You Do?
- Check if you have this product: (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, 133, 350, 263, 3, 32, 175, 229, 304, 124, 307, 220, 79, 60, 311, 146, 147, 319, 188, 74, 8, 9, 94, 134, 82, 143, 86, 286, 96, 227, 231, 329, 126, 162, 299, 35, 11, 259, 180, 160, 196, 322, 208, 282, 13, 178, 4, 132, 131, 209, (2) System Code: 722231; UDI: 00884838099258; System Serial Number: 13, 52, 49, 50, 41, 68, 21, 53, 67, 47, 3, 17, 18, 25, 72, 87, 93, 94, 34, 69, 61, 26, 80, 6, 7, 8, 4, 5, 60, 12, 63, 73, 14, 48, 56, 28, 66, 75, 81, 45, 20, 19, 51, 29, 27, 11, 35, 62, 54, 33, 92, 1, 2, 32, 59;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Azurion 5 M12; System Code: (1)722227, (2)722231;
Product Codes/Lot Numbers:
(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, 133, 350, 263, 3, 32, 175, 229, 304, 124, 307, 220, 79, 60, 311, 146, 147, 319, 188, 74, 8, 9, 94, 134, 82, 143, 86, 286, 96, 227, 231, 329, 126, 162, 299, 35, 11, 259, 180, 160, 196, 322, 208, 282, 13, 178, 4, 132, 131, 209, (2) System Code: 722231; UDI: 00884838099258; System Serial Number: 13, 52, 49, 50, 41, 68, 21, 53, 67, 47, 3, 17, 18, 25, 72, 87, 93, 94, 34, 69, 61, 26, 80, 6, 7, 8, 4, 5, 60, 12, 63, 73, 14, 48, 56, 28, 66, 75, 81, 45, 20, 19, 51, 29, 27, 11, 35, 62, 54, 33, 92, 1, 2, 32, 59;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1679-2026
Related Recalls
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
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During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.