Allura Xper FD20/15; Model Numbers: 722058; 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: 722058; UDI-DI: 00884838059115; Serial Numbers: 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 172, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 366, 340, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 399, 72, 332, 92, 142, 67, 106, 335, 360, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 288, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 48, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 101, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 370, 387, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 379, 331, 418, 356, 421, 369, 420, 397, 357, 408, 393, 388, 108, 211, 126, 125, 301, 12, 30, 355, 354, 159, 139, 128, 81, 58, 96, 343, 177, 115, 19, 18, 311, 220, 386, 291, 327, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 400, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
- 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 FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Product Codes/Lot Numbers:
Model Numbers: 722058; UDI-DI: 00884838059115; Serial Numbers: 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 172, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 366, 340, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 399, 72, 332, 92, 142, 67, 106, 335, 360, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 288, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 48, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 101, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 370, 387, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 379, 331, 418, 356, 421, 369, 420, 397, 357, 408, 393, 388, 108, 211, 126, 125, 301, 12, 30, 355, 354, 159, 139, 128, 81, 58, 96, 343, 177, 115, 19, 18, 311, 220, 386, 291, 327, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 400, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0010-2026
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.
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.
Philips Azurion 3M12, Model Numbers: 722063, 722221 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.
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.
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 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.
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.