Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

Recall details

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Distributor

Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, 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, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

Lot

1. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 445, 1555, 1114, 1529, 472, 1349, 1594, 1311, 1472, 1187, 1700, 1031, 912, 913, 940, 285, 1637, 5, 797, 639, 452, 1585, 535, 1338, 1641, 1916, 614, 605, 492, 1612, 505, 239, 1216, 1169, 1118, 115, 519, 356, 715, 423, 1399, 789, 1509, 1016, 875, 1923, 313, 314, 1919, 1458, 369, 1176, 1230, 1925, 339, 1325, 1633, 596, 1784, 464, 796, 1928, 1025, 292, 1669, 1697, 708, 1, 1760, 1452, 346, 961, 1172, 354, 416, 363, 582, 161, 569, 922; 2. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794, (01)00884838059030(21)939, (01)00884838059030(21)921, (01)00884838059030(21)286, (01)00884838059030(21)1440, (01)00884838059030(21)1144, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)107, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)656, (01)00884838059030(21)1261, (01)00884838059030(21)1170, (01)00884838059030(21)585, (01)00884838059030(21)1128, (01)00884838059030(21)882, (01)00884838059030(21)1230, (01)00884838059030(21)280, (01)00884838059030(21)488, (01)00884838059030(21)787, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)190, (01)00884838059030(21)1181, (01)00884838059030(21)694, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)1149, (01)00884838059030(21)423, (01)00884838059030(21)1176, (01)00884838059030(21)1173, (01)00884838059030(21)1040, (01)00884838059030(21)1309, (01)00884838059030(21)763, (01)00884838059030(21)931, (01)00884838059030(21)478, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)290, (01)00884838059030(21)365, (01)00884838059030(21)651, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)1336, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)00884838059030(21)467, (01)00884838059030(21)1369, (01)00884838059030(21)792, (01)00884838059030(21)679, (01)00884838059030(21)485, (01)00884838059030(21)395, (01)00884838059030(21)592, (01)00884838059030(21)1312, (01)00884838059030(21)1302, (01)00884838059030(21)505, (01)00884838059030(21)714, (01)00884838059030(21)414, (01)00884838059030(21)785, (01)00884838059030(21)1283, (01)00884838059030(21)119, (01)00884838059030(21)662, (01)00884838059030(21)698, (01)00884838059030(21)690, (01)00884838059030(21)1235, (01)00884838059030(21)1233, (01)00884838059030(21)1236, (01)00884838059030(21)1234, (01)00884838059030(21)158, (01)00884838059030(21)1009, (01)00884838059030(21)992, (01)00884838059030(21)1214, (01)00884838059030(21)1064, (01)00884838059030(21)979, (01)00884838059030(21)764, (01)00884838059030(21)920, (01)00884838059030(21)788, (01)00884838059030(21)1396, (01)00884838059030(21)902, (01)00884838059030(21)1344, (01)00884838059030(21)1183, (01)00884838059030(21)453, (01)00884838059030(21)1118, (01)00884838059030(21)411, (01)00884838059030(21)1210, (01)00884838059030(21)1209, (01)00884838059030(21)1041, (01)00884838059030(21)1042, (01)00884838059030(21)1432, (01)00884838059030(21)308, (01)00884838059030(21)833, (01)00884838059030(21)1310, (01)00884838059030(21)728, (01)00884838059030(21)791, (01)00884838059030(21)480, (01)00884838059030(21)1263, (01)00884838059030(21)987, (01)00884838059030(21)986, (01)00884838059030(21)422, (01)00884838059030(21)905, (01)00884838059030(21)218, (01)00884838059030(21)1005, (01)00884838059030(21)1425, (01)00884838059030(21)1397, (01)00884838059030(21)1398, (01)00884838059030(21)1132, (01)00884838059030(21)468, (01)00884838059030(21)1442, (01)00884838059030(21)1048, (01)00884838059030(21)648, (01)00884838059030(21)646, (01)00884838059030(21)1126, (01)00884838059030(21)873, (01)00884838059030(21)252, (01)00884838059030(21)343, (01)0088

Risk classification

Class II

Area (FDA)

device

Country

Netherlands