United StatesAllura Xper FD10C (System Code 722001) and multiple related Philips systems — including Allura Xper FD10F, FD10, FD20 variants, FD20/10, FD20/20, Azurion 3 M12 and seven other products — are affected; they can be identified by the product names, system codes (for example 722001–722063 and others) and the listed system serial numbers. Philips recalled them because it identified instances where X‑ray imaging may not initiate or may occur intermittently when using the wired foot switch.
What's being recalled
Allura Xper FD10C; System Code: 722001;
ALLURA Xper FD10F; System Code: 722002;
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Allura Xper FD20/10; System Code: 722029;
Allura Xper FD20/20; System Code: 722038;
Allura Xper FD20/20 OR Table; System Code: 722039;
Allura Xper FD20/15; System Code: 722058;
Allura Xper FD20/15 OR Table; System Code: 722059;
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
And 7 more products.
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
System Code: 722001; UDI: N/A; System Serial Number: 19, 249, 21, 18661014, 77, 82, 195, 216, 337, 37, 258, 283, 15, 256, 305; System Code: 722002; UDI: N/A; System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40; (1) System Code: 722003; UDI: N/A; System Serial Number: 445, 1555, 1084, 1411, 1232, 1259, 1023, 1947, 392, 1133, 1135, 1627, 746, 98, 1078, 367, 1584, 1599, 1153, 1154, 1032, 1694, 259, 1471, 1474, 684, 657, 385, 1551, 947, 1360, 1482, 1489, 177, 1634, 1663, 1704, 1214, 546, 1089, 305, 2936, 92, 1092, 1869, 119, 928, 1449, 1805, 998, 501, 503, 1114, 345, 1443, 1444, 8198, 63, 1189, 1954, 1575, 1728, 1430, 147, 1326, 700, 1446, 401, 1615, 939, 527, 1067, 1787, 1529, 104, 342, 390, 1353, 159, 160, 472, 197, 1349, 1271, 653, 917, 997616, 1072, 1594, 574, 892, 1138, 1001, 1950, 447, 1043, 994, 995, 1514, 1525, 1311, 8091, 1472, 1621, 1622, 72, 1187, 1222, 1948, 963, 1700, 1343, 619915, 1667, 463, 959, 1031, 912, 913, 1647, 521, 590, 591, 855, 328A, 696, 1807, 690, 1714, 37, 1799, 1286, 257, 1188, 940, 1512, 1891, 1223, 640, 103, 24, 406, 467, 285, 1637, 453, 833, 1738, 1749, 430, 1491, 1605, 1130, 5, 674, 639, 797, 1033, 1357, 1632, 1631, 391, 281, 1535, 1038, 1045, 1536, 350, 452, 629, 732, 754, 1056, 810, 1610, 1611, 1804, 1122, 1413, 644, 1059, 513, 1163, 1193, 1549, 418, 1778, 1199, 2933, 517, 1597, 1585, 1063, 1596, 337, 1746, 1747, 1619, 288, 988, 535, 1717, 1641, 1395, 411, 412, 413, 414, 415, 1338, 319, 1706, 1572, 1916, 1282, 789, 614, 763, 728, 605, 622, 492, 1612, 1648, 1613, 1568, 1569, 1685, 948, 505, 566, 1297, 895619, 1277, 321, 239, 1216, 328, 329, 190, 1586, 1492, 863, 1616, 359, 1169, 1118, 230, 1421, 1416, 1260, 1609, 115, 1337, 519, 370, 1155, 13, 162, 1478, 1090, 1662, 1818, 1730, 1463, 1752, 1215, 1558, 1578, 1083, 1014, 1378, 985, 1231, 356, 307, 308, 309, 310, 777, 778, 780, 1127, 1167, 1186, 1638, 898, 82, 136, 1646, 1689, 715, 423, 1571, 1101, 1399, 1931, 1149, 753, 1255, 424, 1733, 606, 1247, 751, 1293, 548, 813, 1524, 1457…
The hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
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;
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada