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healthClass IIRecalled on Oct 1, 2025

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563

🔢 2114 units (791 US, 1323 OUS)

Sold At: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.(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 #: FDA-DEVICE-Z-2626-2025

Source: FDA-ENFORCEMENT

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563

Product Identification

Lot/Batch Codes:
Product Codes: (1)722012, (2) 722028, (3) 722006; UDI-DI: (1) 00884838059054, (2) 00884838054202, (3) N/A; Serial numbers: (1) 919, 1581, 1117, 1001, 1673, 1712, 585, 517, 1545, 1715, 504, 757, 935, 1356, 1250, 1613, 2006, 1440, 1550, 1733, 1734, 2201, 1922, 741, 2283, 1034, 1359, 1848, 950, 2943, 865, 1908, 1166, 1113, 1804, 100, 1408, 590, 2508, 1279, 2509, 452, 2151, 1724, 2134, 481, 543, 893, 1455, 2085, 423, 1282, 2307, 1798, 1656, 990, 1806, 1871, 2506, 1652, 894, 2920, 1189, 1099, 1038, 1058, 566, 823, 1037, 924, 2319, 2310, 1610, 686, 2933, 2514, 1108, 500, 459, 1422, 1035, 84, 1649, 1895, 1900, 1723, 878, 2221, 464, 2496, 2222, 1515, 1731, 1017, 1020, 380, 1811, 527, 2171, 418, 1053, 1558, 1336, 601, 1014, 1265, 331, 389, 732, 751, 1324, 2276, 684, 2219, 814, 815, 1120, 297, 1713, 580, 1098, 1852, 1307, 1858, 758, 2054, 856, 1690, 1407, 480, 579, 1327, 695, 733, 1506, 1091, 1254, 797, 213, 1280, 828, 1118, 1249, 542, 1033, 2265, 490, 920, 1209, 470, 1075, 2203, 1396, 444, 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353, 1845, 1653, 633056, 1889, 372, 1648, 722008-358, 1790, 1100, 1373, 1270, 1591, 1022, 768, 2304, 2371, 336, 351, 352, 2046, 555, 125, 1255, 1712, 666, 284, 2416, 516, 455, 1787, 417, 1819, 1880, 867, 1003, 2488, 380, 2438, 1031, 2095, 1784, 2115, 1530, 2245, 408, 245, 428, 1817, 1891, 2061, 833, 2278, 2348, 477, 1554, 1763, 902, 2307, 1561, 1916, 102, 1998, 1948, 2293, 2369, SN002458/100099178, 1692, 2015, 164, 1791, 1668, 585, 2171, PSO.6002064, 259, 1949, 2079, 1568, 241, 424, 872, CV619, 233, 1551, 2010, 89, 940, 2598, 457, 799, 866, 2124, 346, 2520, 2475, 1264, 1687, 1504, 1652, 1203, 519, 100079164-1971, 1213, 1509, 1708, 994, 31, 123456, NA, 1350, 83491, 33, 1533, 1219, 460, 2230, 1618, 717, 1539KR, 1876, 1021, 1559KR, 594, 2528, 2517, 1557, 1408, 462, 1193, 1605;

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Summary

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 to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.