🔍 RecallPedia

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

Class I - Dangerous
🏥 Medical Devices Recalled: January 13, 2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog numbers: (1) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403, 228, 208, 40, 45, 66, 135, 136, 11, 96, 417, 156, 84, 190, 277, 256, 131, 148, 161, 162, 12, 57, 6, 69, 408, 282, 123, 62, 184, 51, 89, 100, 137, 61, 222, 50, 143, 49, 268, 7, 119, 118, 384, 68, 65, 121, 87, 180, 185, 193, 212, 213, 214, 266, 271, 72, 37, 245, 108, 91, 252, 292, 293, 321, 379, 138, 60, 130, 157, 263, 264, 110, 109, 133, 79, 490, 155, 451, 511, 484, 497, 67, 272, 323, 132, 102, 253, 275, 70, 251, 421, 43, 254, 106, 104, 122, 191, 47, 378, 75, 381, 227, 92, 207, 117, 126, 175, 166, 172, 429, 296, 114, 437, 294, 295, 419, 134, 188, 189, 283, 315, 284, 210, 116, 187, 199, 434, 241, 357, 313, 192, 255, 306, 164, 215, 319, 327, 144, 221, 5, 250, 46, 101, 431, 9, 177, 39, 226, 290, 393, 257, 78, 183, 269, 80, 425, 206, 309, 173, 220, 359, 354, 374, 41, 186, 48, 44, 149, 150, 176, 197, 230, 231, 233, 287, 288, 289, 380, 124, 373, 98, 147, 391, 345, 303; (2) 15, 19, 55, 265, 23, 226, 255, 254, 256, 257, 12, 99, 100, 120, 45, 187, 223, 367, 332, 44, 358, 69, 310, 17, 111, 356, 112, 113, 106, 51, 65, 188, 268, 77, 11, 109, 80, 68, 245, 83, 250, 251, 252, 253, 248, 270, 47, 21, 38, 54, 272, 64, 261, 165, 98, 211, 67, 326, 29, 10, 22, 173, 127, 368, 262, 190, 225, 184, 166, 143, 312, 322, 297, 364, 219, 189, 304, 183, 162, 168, 349, 318, 333, 169, 185, 311, 228, 180, 172, 296, 217, 181, 224, 278, 186, 161, 247, 193, 266, 313, 282, 244, 177, 50, 280, 354, 75, 246, 269, 126, 78, 108, 105, 124, 218, 125, 35, 146, 13, 300, 5, 9, 18, 249, 27, 31, 104, 53, 76, 107, 243, 66, 215, 267, 324, 281, 229, 213, 117, 178, 92, 287, 88, 89, 102, 118, 119, 145, 209, 210, 331, 351, 361, 372, 373, 288, 289, 290, 291, 292, 294, 295, 319, 212, 192, 149, 321, 115, 82, 316, 133, 174, 230, 307, 320, 336, 338, 339, 340, 344, 362, 141, 37, 182, 308, 142, 96, 378, 365, 366, 370, 374, 135, 73, 159, 157, 158, 114, 87, 274, 214, 116, 276, 132, 277, 353, 14, 72, 151, 152, 138, 56, 137, 302, 363, 4, 24, 90, 131, 263, 16, 314, 315, 110, 305, 139, 134, 222, 369, 375, 284, 48 ****Serial numbers Added 5/2/2025**** 328, 335,343, 345, 346, 376, 379, 380, 382, 383, 384, 385, 386, 389, 392, 396; (3) (OUS ONLY) 79, 196, 126, 131, 142, 143, 144, 133, 162, 152, 167, 44, 129, 199, 147, 112, 98, 36, 137, 101, 150, 210, 170, 34, 123, 125, 124, 113, 39, 81, 42, 41, 93, 37, 100, 95, 22, 43, 171, 58, 49, 158, 20, 19, 88, 87, 165, 207, 63, 76, 48, 164, 83, 54, 45, 38, 179, 127, 175, 157, 128, 140, 99, 132, 35, 145, 91, 92, 96, 161, 205, 66, 174, 74, 69, 209, 206, 61, 118, 84, 94, 108, 148, 24, 72, 105, 208, 47, 33, 53, 90, 187, 130, 57, 85, 86, 153, 80, 106, 149, 55, 173, 103, 177, 178, 119, 46, 135, 17, 107, 65, 102, 141, 160, 52, 71, 60, 59, 120, 189, 114, 97, 73, 50, 82, 21, 30, 23, 110, 40, 151, 146, 117 ****Serial Numbers Added 5/2/2025**** 68, 138, 194, 197, 198, 204, 211, 212, 215, 216, 218, 220, 226, 231.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Possibility of the patient falling from the table related to the mattress used on the patient table.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

Product Codes/Lot Numbers:

Catalog numbers: (1) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403, 228, 208, 40, 45, 66, 135, 136, 11, 96, 417, 156, 84, 190, 277, 256, 131, 148, 161, 162, 12, 57, 6, 69, 408, 282, 123, 62, 184, 51, 89, 100, 137, 61, 222, 50, 143, 49, 268, 7, 119, 118, 384, 68, 65, 121, 87, 180, 185, 193, 212, 213, 214, 266, 271, 72, 37, 245, 108, 91, 252, 292, 293, 321, 379, 138, 60, 130, 157, 263, 264, 110, 109, 133, 79, 490, 155, 451, 511, 484, 497, 67, 272, 323, 132, 102, 253, 275, 70, 251, 421, 43, 254, 106, 104, 122, 191, 47, 378, 75, 381, 227, 92, 207, 117, 126, 175, 166, 172, 429, 296, 114, 437, 294, 295, 419, 134, 188, 189, 283, 315, 284, 210, 116, 187, 199, 434, 241, 357, 313, 192, 255, 306, 164, 215, 319, 327, 144, 221, 5, 250, 46, 101, 431, 9, 177, 39, 226, 290, 393, 257, 78, 183, 269, 80, 425, 206, 309, 173, 220, 359, 354, 374, 41, 186, 48, 44, 149, 150, 176, 197, 230, 231, 233, 287, 288, 289, 380, 124, 373, 98, 147, 391, 345, 303; (2) 15, 19, 55, 265, 23, 226, 255, 254, 256, 257, 12, 99, 100, 120, 45, 187, 223, 367, 332, 44, 358, 69, 310, 17, 111, 356, 112, 113, 106, 51, 65, 188, 268, 77, 11, 109, 80, 68, 245, 83, 250, 251, 252, 253, 248, 270, 47, 21, 38, 54, 272, 64, 261, 165, 98, 211, 67, 326, 29, 10, 22, 173, 127, 368, 262, 190, 225, 184, 166, 143, 312, 322, 297, 364, 219, 189, 304, 183, 162, 168, 349, 318, 333, 169, 185, 311, 228, 180, 172, 296, 217, 181, 224, 278, 186, 161, 247, 193, 266, 313, 282, 244, 177, 50, 280, 354, 75, 246, 269, 126, 78, 108, 105, 124, 218, 125, 35, 146, 13, 300, 5, 9, 18, 249, 27, 31, 104, 53, 76, 107, 243, 66, 215, 267, 324, 281, 229, 213, 117, 178, 92, 287, 88, 89, 102, 118, 119, 145, 209, 210, 331, 351, 361, 372, 373, 288, 289, 290, 291, 292, 294, 295, 319, 212, 192, 149, 321, 115, 82, 316, 133, 174, 230, 307, 320, 336, 338, 339, 340, 344, 362, 141, 37, 182, 308, 142, 96, 378, 365, 366, 370, 374, 135, 73, 159, 157, 158, 114, 87, 274, 214, 116, 276, 132, 277, 353, 14, 72, 151, 152, 138, 56, 137, 302, 363, 4, 24, 90, 131, 263, 16, 314, 315, 110, 305, 139, 134, 222, 369, 375, 284, 48 ****Serial numbers Added 5/2/2025**** 328, 335,343, 345, 346, 376, 379, 380, 382, 383, 384, 385, 386, 389, 392, 396; (3) (OUS ONLY) 79, 196, 126, 131, 142, 143, 144, 133, 162, 152, 167, 44, 129, 199, 147, 112, 98, 36, 137, 101, 150, 210, 170, 34, 123, 125, 124, 113, 39, 81, 42, 41, 93, 37, 100, 95, 22, 43, 171, 58, 49, 158, 20, 19, 88, 87, 165, 207, 63, 76, 48, 164, 83, 54, 45, 38, 179, 127, 175, 157, 128, 140, 99, 132, 35, 145, 91, 92, 96, 161, 205, 66, 174, 74, 69, 209, 206, 61, 118, 84, 94, 108, 148, 24, 72, 105, 208, 47, 33, 53, 90, 187, 130, 57, 85, 86, 153, 80, 106, 149, 55, 173, 103, 177, 178, 119, 46, 135, 17, 107, 65, 102, 141, 160, 52, 71, 60, 59, 120, 189, 114, 97, 73, 50, 82, 21, 30, 23, 110, 40, 151, 146, 117 ****Serial Numbers Added 5/2/2025**** 68, 138, 194, 197, 198, 204, 211, 212, 215, 216, 218, 220, 226, 231.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1154-2025

Related Recalls

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

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.

Class I - Dangerous

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.

Dec 7, 2023 Other Medical Devices Nationwide View Details →