Allura Xper FD20 Biplane recall
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Why was Allura Xper FD20 Biplane recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 268 units (102 US, 166 OUS)
- Distribution
- 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.
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)