ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    (1) System Code: 722008; UDI: N/A; System Serial Number: 360, 361, 445, 296, 487, 390, 306, 178, 420, 267, 245, 2470, 491, 113, 386, 69, 413, 365, 454, 304, 442, 125, 441, 320, 325, 112, 254, 456, 52, 34, 239, 407, 187, 437, 82, 102, 288, 349, 106, 105, 481, 71, 424, 1236, 197, 264, 18, 19, 192, 124, 483, 244, 224, 470, 279, 141, 459, 357, 287, 116, 521, 369, 212, 23, 415, 100, 294, 270, 372, 472, 18270, 154, 231, 108, 1178, 246, 115, 460, 319, 465, 142, 419, 312, 37, 59, 455, 217, 350, 406, 160, 167, 435, 447, 410, 196, 458, 480, 476, 370, 169, 121, 259, 266, 186, 290, 253, 359, 391, 283, 205, 425, 346, 376, 150, 394, 123, 513, 337, 93, 268, 200, 87, 110, 46, 542, 334, 122, 8, 468, 250, 482, 63, 408, 305, 213, 547, 546, 475, 356, 404, 398, 31, 553; (2) System Code: 722013; UDI: 00884838059061; System Serial Number: 293, 424, 100, 174, 86, 83, 46, 170, 218, 441, 249, 639, 290, 153, 410, 1, 289, 518, 519, 626, 126, 141, 496, 379, 115, 42, 601, 214, 637, 360, 389, 303, 268, 264, 631, 254, 255, 515, 129, 15, 603, 278, 347, 426, 505, 109, 462, 149, 124, 216, 246, 84, 479, 69, 105, 638, 375, 531, 404, 575, 147, 475, 262, 125, 316, 497, 357, 495, 573, 342, 564, 164, 178, 556, 253, 297, 511, 492, 43, 550, 96, 179, 228, 194, 151, 106, 330, 461, 304, 40, 85, 72, 241, 422, 267, 150, 428, 634, 327, 442, 175, 217, 313, 346, 308, 562, 309, 152, 34, 561, 35, 205, 61, 435, 266, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 138, 223, 343, 165, 453, 370, 367, 108, 352, 291, 259, 455, 368, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 560, 300, 295, 448, 81, 444, 400, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 476, 527, 276, 247, 156, 499, 50, 302, 618, 608, 133, 70, 457, 547, 312, 366, 390, 544, 236, 157, 243, 144, 238, 525, 53, 570, 161, 349, 359, 454, 613, 623, 222, 215, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 470, 378, 296, 227, 31, 58, 589, 616, 71, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 528, 318, 28, 237, 559, 372, 256, 374, 487, 405, 380, 434, 130, 473, 551, 557, 294, 412, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 622, 182, 574, 139, 137, 250, 563, 502, 450, 436, 406, 354, 510, 395, 458, 261, 348, 503, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 522, 64, 208, 408, 555, 394, 57, 493;
  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:
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:

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

Product Codes/Lot Numbers:

(1) System Code: 722008; UDI: N/A; System Serial Number: 360, 361, 445, 296, 487, 390, 306, 178, 420, 267, 245, 2470, 491, 113, 386, 69, 413, 365, 454, 304, 442, 125, 441, 320, 325, 112, 254, 456, 52, 34, 239, 407, 187, 437, 82, 102, 288, 349, 106, 105, 481, 71, 424, 1236, 197, 264, 18, 19, 192, 124, 483, 244, 224, 470, 279, 141, 459, 357, 287, 116, 521, 369, 212, 23, 415, 100, 294, 270, 372, 472, 18270, 154, 231, 108, 1178, 246, 115, 460, 319, 465, 142, 419, 312, 37, 59, 455, 217, 350, 406, 160, 167, 435, 447, 410, 196, 458, 480, 476, 370, 169, 121, 259, 266, 186, 290, 253, 359, 391, 283, 205, 425, 346, 376, 150, 394, 123, 513, 337, 93, 268, 200, 87, 110, 46, 542, 334, 122, 8, 468, 250, 482, 63, 408, 305, 213, 547, 546, 475, 356, 404, 398, 31, 553; (2) System Code: 722013; UDI: 00884838059061; System Serial Number: 293, 424, 100, 174, 86, 83, 46, 170, 218, 441, 249, 639, 290, 153, 410, 1, 289, 518, 519, 626, 126, 141, 496, 379, 115, 42, 601, 214, 637, 360, 389, 303, 268, 264, 631, 254, 255, 515, 129, 15, 603, 278, 347, 426, 505, 109, 462, 149, 124, 216, 246, 84, 479, 69, 105, 638, 375, 531, 404, 575, 147, 475, 262, 125, 316, 497, 357, 495, 573, 342, 564, 164, 178, 556, 253, 297, 511, 492, 43, 550, 96, 179, 228, 194, 151, 106, 330, 461, 304, 40, 85, 72, 241, 422, 267, 150, 428, 634, 327, 442, 175, 217, 313, 346, 308, 562, 309, 152, 34, 561, 35, 205, 61, 435, 266, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 138, 223, 343, 165, 453, 370, 367, 108, 352, 291, 259, 455, 368, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 560, 300, 295, 448, 81, 444, 400, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 476, 527, 276, 247, 156, 499, 50, 302, 618, 608, 133, 70, 457, 547, 312, 366, 390, 544, 236, 157, 243, 144, 238, 525, 53, 570, 161, 349, 359, 454, 613, 623, 222, 215, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 470, 378, 296, 227, 31, 58, 589, 616, 71, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 528, 318, 28, 237, 559, 372, 256, 374, 487, 405, 380, 434, 130, 473, 551, 557, 294, 412, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 622, 182, 574, 139, 137, 250, 563, 502, 450, 436, 406, 354, 510, 395, 458, 261, 348, 503, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 522, 64, 208, 408, 555, 394, 57, 493;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1664-2026

Related Recalls

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 →

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 →

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 →