Recall Ledger

ALLURA Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Medical deviceClass IIOngoing

Summary: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;. Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

What is being recalled

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

Why

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., 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, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen; (states named: Georgia)

How to tell if yours is affected

(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;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1664-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMarch 3, 2026
ReportedApril 8, 2026
CompanyPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Company locationBest, Netherlands
Initiated byVoluntary: Firm initiated
Quantity461 units (198 US, 263 OUS)

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