Recall archive / FDA device enforcement

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K1332... — FDA record Z-0006-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Reason: 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 II
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 501 units (212 US, 289 OUS)
Agency-reported status: Ongoing
Source record identifier: Z-0006-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Model Numbers: (1) 722008, (2) 722013; UDI-DI: (1) N/A, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 125, 312, 319, 82, 192, 244, 453, 306, 116, 124, 18270, 524, 106, 224, 463, 197, 264, 100, 294, 246, 357, 212, 287, 154, 459, 71, 112, 472, 483, 465, 419, 38, 454, 2470, 441, 460, 369, 407, 102, 231, 94, 437, 420, 1178, 108, 270, 442, 521, 372, 113, 34, 187, 254, 365, 390, 413, 52, 18, 19, 239, 288, 424, 279, 115, 481, 141, 304, 267, 361, 415, 178, 245, 445, 23, 296, 487, 349, 456, 470, 386, 69, 1236, 37, 59, 455, 217, 446, 272, 160, 406, 350, 167, 247, 416, 435, 48, 447, 179, 410, 196, 458, 525, 480, 476, 370, 327, 169, 121, 259, 266, 128, 186, 290, 385, 253, 450, 359, 391, 283, 323, 205, 425, 346, 388, 376, 150, 394, 123, 339, 513, 337, 93, 268, 200, 87, 110, 46, 542, 530, 334, 122, 468, 250, 482, 63, 305, 213, 546, 273, 433, 475, 398, 31, (2) 505, 313, 217, 492, 34, 410, 153, 360, 290, 74, 83, 241, 404, 126, 244, 106, 383, 346, 461, 307, 1, 442, 435, 293, 253, 297, 46, 289, 638, 342, 69, 267, 402, 214, 86, 603, 149, 424, 140, 254, 255, 266, 475, 519, 518, 303, 194, 115, 150, 129, 496, 599, 441, 124, 151, 179, 550, 377, 575, 631, 562, 178, 330, 309, 601, 327, 308, 264, 78, 268, 141, 175, 357, 85, 40, 216, 637, 422, 174, 109, 72, 218, 228, 511, 389, 152, 479, 561, 262, 626, 61, 164, 497, 170, 379, 84, 125, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 205, 246, 43, 639, 304, 634, 147, 15, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 343, 223, 385, 165, 453, 370, 22, 367, 108, 352, 291, 71, 259, 455, 468, 368, 239, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 184, 185, 187, 188, 437, 189, 183, 186, 190, 413, 191, 560, 490, 300, 295, 81, 448, 444, 400, 632, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 48, 476, 527, 276, 247, 156, 499, 50, 167, 132, 302, 618, 608, 265, 70, 457, 547, 312, 321, 366, 390, 544, 236, 157, 243, 144, 525, 238, 570, 161, 349, 359, 454, 613, 623, 222, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 509, 470, 378, 296, 227, 31, 58, 589, 616, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 2266, 528, 318, 29, 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, 524, 354, 510, 395, 458, 261, 503, 348, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 501, 522, 64, 396, 408, 208, 555, 394, 57, 493, 201;

Label field

Details supplied by the agency

Lot, code or applicability

Model Numbers: (1) 722008, (2) 722013; UDI-DI: (1) N/A, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 125, 312, 319, 82, 192, 244, 453, 306, 116, 124, 18270, 524, 106, 224, 463, 197, 264, 100, 294, 246, 357, 212, 287, 154, 459, 71, 112, 472, 483, 465, 419, 38, 454, 2470, 441, 460, 369, 407, 102, 231, 94, 437, 420, 1178, 108, 270, 442, 521, 372, 113, 34, 187, 254, 365, 390, 413, 52, 18, 19, 239, 288, 424, 279, 115, 481, 141, 304, 267, 361, 415, 178, 245, 445, 23, 296, 487, 349, 456, 470, 386, 69, 1236, 37, 59, 455, 217, 446, 272, 160, 406, 350, 167, 247, 416, 435, 48, 447, 179, 410, 196, 458, 525, 480, 476, 370, 327, 169, 121, 259, 266, 128, 186, 290, 385, 253, 450, 359, 391, 283, 323, 205, 425, 346, 388, 376, 150, 394, 123, 339, 513, 337, 93, 268, 200, 87, 110, 46, 542, 530, 334, 122, 468, 250, 482, 63, 305, 213, 546, 273, 433, 475, 398, 31, (2) 505, 313, 217, 492, 34, 410, 153, 360, 290, 74, 83, 241, 404, 126, 244, 106, 383, 346, 461, 307, 1, 442, 435, 293, 253, 297, 46, 289, 638, 342, 69, 267, 402, 214, 86, 603, 149, 424, 140, 254, 255, 266, 475, 519, 518, 303, 194, 115, 150, 129, 496, 599, 441, 124, 151, 179, 550, 377, 575, 631, 562, 178, 330, 309, 601, 327, 308, 264, 78, 268, 141, 175, 357, 85, 40, 216, 637, 422, 174, 109, 72, 218, 228, 511, 389, 152, 479, 561, 262, 626, 61, 164, 497, 170, 379, 84, 125, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 205, 246, 43, 639, 304, 634, 147, 15, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 343, 223, 385, 165, 453, 370, 22, 367, 108, 352, 291, 71, 259, 455, 468, 368, 239, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 184, 185, 187, 188, 437, 189, 183, 186, 190, 413, 191, 560, 490, 300, 295, 81, 448, 444, 400, 632, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 48, 476, 527, 276, 247, 156, 499, 50, 167, 132, 302, 618, 608, 265, 70, 457, 547, 312, 321, 366, 390, 544, 236, 157, 243, 144, 525, 238, 570, 161, 349, 359, 454, 613, 623, 222, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 509, 470, 378, 296, 227, 31, 58, 589, 616, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 2266, 528, 318, 29, 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, 524, 354, 510, 395, 458, 261, 503, 348, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 501, 522, 64, 396, 408, 208, 555, 394, 57, 493, 201;

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Oct 8, 2025
Recall initiation date: Sep 3, 2025
Center classification date: Oct 1, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records