Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) N/A, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 233, 321, 435, 285, 384, 388, 343, 399, 392, 128, 355, 51, 367, 348, 160, 271, 530, 112, 70, 520, 323, 49, 329, 365, 269, 270, 523, 490, 346, 129, 258, 298, 316, 485, 261, 169, 427, 352, 474, 497, 251, 100, 456, 360, 305, 419, 405, 489, 306, 307, 467, 234, 333, 533, 209, 369, 543, 332, 328, 366, 339, 389, 538, 394, 378, 379, 237, 165, 2724, 238, 415, 473, 482, 397, 53, 385, 52, 447, 96, 429, 159, 531, 58, 499, 229, 374, 25, 354, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 561, 511, 478, 428, 500, 464, 463, 14, 459, 416, 359, 487, 564, 469, 72, 125, 494, 76, (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 79, 76, 17, 87, 255, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 189, 186, 118, 119, 300, 213, 372, 12, 55, 41, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 75, 307, 301, 18, 302, 303, 304, 305, 306, 293, 294, 184, 266, 146, 116, 68, 310, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 141, 139, 77, 99, 277, 313, 223, 27, 26, 29, 340, 69, 374, 328, 228, 251, 231, 323, 224, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 86, 378, 376, 377, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 104, 290, 244, 333, 287, 38, 39, 176, 282, 216, 158, 329, 246, 295, 56, 337, 292, 125, (3) 203, 335, 123, 133, 134, 284, 280, 183, 169, 106, 107, 234, 42, 101, 307, 265, 306, 267, 209, 153, 40, 332, 156, 112, 305, 1, 104, 263, 342, 71, 255, 351, 298, 175, 120, 116, 174, 241, 240, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 293, 292, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 338, 334, 162, 273, 5, 160, 246, 61, 36, 299, 294, 345, 76, 94, 350, 348, 349, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 126, 81, 268, 356, 244, 221, 55, 86, 254, 6, 117, 113, 362, 271, 186, 259, 236, 201, 275, 135, 277, 3, 58, 249, 149, 148, 38, 47, 316, 27, 165, 274, 80, 64, 205, 223, 270, 181, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 214, 145, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 243, 242, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 23, 24, 21, 20, 65;
- 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:
- The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
- 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 FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Product Codes/Lot Numbers:
Model Numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) N/A, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 233, 321, 435, 285, 384, 388, 343, 399, 392, 128, 355, 51, 367, 348, 160, 271, 530, 112, 70, 520, 323, 49, 329, 365, 269, 270, 523, 490, 346, 129, 258, 298, 316, 485, 261, 169, 427, 352, 474, 497, 251, 100, 456, 360, 305, 419, 405, 489, 306, 307, 467, 234, 333, 533, 209, 369, 543, 332, 328, 366, 339, 389, 538, 394, 378, 379, 237, 165, 2724, 238, 415, 473, 482, 397, 53, 385, 52, 447, 96, 429, 159, 531, 58, 499, 229, 374, 25, 354, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 561, 511, 478, 428, 500, 464, 463, 14, 459, 416, 359, 487, 564, 469, 72, 125, 494, 76, (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 79, 76, 17, 87, 255, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 189, 186, 118, 119, 300, 213, 372, 12, 55, 41, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 75, 307, 301, 18, 302, 303, 304, 305, 306, 293, 294, 184, 266, 146, 116, 68, 310, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 141, 139, 77, 99, 277, 313, 223, 27, 26, 29, 340, 69, 374, 328, 228, 251, 231, 323, 224, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 86, 378, 376, 377, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 104, 290, 244, 333, 287, 38, 39, 176, 282, 216, 158, 329, 246, 295, 56, 337, 292, 125, (3) 203, 335, 123, 133, 134, 284, 280, 183, 169, 106, 107, 234, 42, 101, 307, 265, 306, 267, 209, 153, 40, 332, 156, 112, 305, 1, 104, 263, 342, 71, 255, 351, 298, 175, 120, 116, 174, 241, 240, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 293, 292, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 338, 334, 162, 273, 5, 160, 246, 61, 36, 299, 294, 345, 76, 94, 350, 348, 349, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 126, 81, 268, 356, 244, 221, 55, 86, 254, 6, 117, 113, 362, 271, 186, 259, 236, 201, 275, 135, 277, 3, 58, 249, 149, 148, 38, 47, 316, 27, 165, 274, 80, 64, 205, 223, 270, 181, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 214, 145, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 243, 242, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 23, 24, 21, 20, 65;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0003-2026
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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.