PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K03373
⚠️ Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 3, 2025
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
What's affected?
- Product
- Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Lot code
- Product Codes: (1)722013, (2) 722008; UDI-DI: (1) 00884838059061, (2) N/A; Serial numbers: (1) 505, 313, 34, 153, 410, 360, 290, 241, 404, 126, 244, 106, 346, 383, 461, 307, 442, 435, 293, 289, 267, 214, 402, 86, 603, 149, 424, 140, 254, 255, 266, 518, 519, 303, 115, 150, 129, 496, 441, 124, 151, 550, 575, 562, 178, 330, 309, 601, 308, 264, 268, 141, 175, 85, 216, 422, 174, 228, 511, 152, 561, 262, 626, 497, 170, 379, 125, 564, 426, 495, 500, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 246, 639, 304, 147, 607, 567, 168, 171, 265, 332, 295, 589, 444, 447, 400, 384, 538, 117, 620, 624, 623, 215, 416, 415, 47, 335, 619, 598, 361, 358, 549, 133, 476, 315, 616, 630, 417, 490, 528, 525, 247, 618, 372, 613, 478, 544, 585, 608, 296, 570, 547, 138, 318, 345, 139, 473, 388, 434, 502, 586, 334, 411, 501, 458, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 250, 595, 406, 355, 57, 394, 535, 569, 522, 465, 533, 412, 95, 344, 354, 425, 542, 207, 555, 524, 574, 366, 527, 325, 470, 440, 144, 403, 448, 134, 380, 487, 374, 256, 405, 367, 455, 302, 300, 299, 239, 506, 243, 324, 311, 70, 161, 449, 321, 176, 181, 554, 167, 130, 378, 158, 237, 453, 165, 532, 223, 343, 291, 370, 193, 163, 526, 236, 156, 368, 499, 443, 540, 259, (2) 224, 105, 312, 197, 264, 294, 246, 231, 521, 413, 18, 19, 267, 487, 69, 386, 205, 416, 513, 337, 327, 122, 259, 150, 547, 408, 160, 388, 283, 359, 435, 370, 323, 128, 455, 266, 468, 46;
Additional details
Product Codes: (1)722013, (2) 722008; UDI-DI: (1) 00884838059061, (2) N/A; Serial numbers: (1) 505, 313, 34, 153, 410, 360, 290, 241, 404, 126, 244, 106, 346, 383, 461, 307, 442, 435, 293, 289, 267, 214, 402, 86, 603, 149, 424, 140, 254, 255, 266, 518, 519, 303, 115, 150, 129, 496, 441, 124, 151, 550, 575, 562, 178, 330, 309, 601, 308, 264, 268, 141, 175, 85, 216, 422, 174, 228, 511, 152, 561, 262, 626, 497, 170, 379, 125, 564, 426, 495, 500, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 246, 639, 304, 147, 607, 567, 168, 171, 265, 332, 295, 589, 444, 447, 400, 384, 538, 117, 620, 624, 623, 215, 416, 415, 47, 335, 619, 598, 361, 358, 549, 133, 476, 315, 616, 630, 417, 490, 528, 525, 247, 618, 372, 613, 478, 544, 585, 608, 296, 570, 547, 138, 318, 345, 139, 473, 388, 434, 502, 586, 334, 411, 501, 458, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 250, 595, 406, 355, 57, 394, 535, 569, 522, 465, 533, 412, 95, 344, 354, 425, 542, 207, 555, 524, 574, 366, 527, 325, 470, 440, 144, 403, 448, 134, 380, 487, 374, 256, 405, 367, 455, 302, 300, 299, 239, 506, 243, 324, 311, 70, 161, 449, 321, 176, 181, 554, 167, 130, 378, 158, 237, 453, 165, 532, 223, 343, 291, 370, 193, 163, 526, 236, 156, 368, 499, 443, 540, 259, (2) 224, 105, 312, 197, 264, 294, 246, 231, 521, 413, 18, 19, 267, 487, 69, 386, 205, 416, 513, 337, 327, 122, 259, 150, 547, 408, 160, 388, 283, 359, 435, 370, 323, 128, 455, 266, 468, 46;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 268 units (102 US, 166 OUS).
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