Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), 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), Cardio Vascular-Allura (722400);

Recall details

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Distributor

Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;

Lot

Code Information: Allura: 1. Allura Xper FD10C; Model: 722001; UDI-DI: N/A; Serial Numbers: 170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F; Model: 722002; UDI-DI: N/A; Serial Numbers: 0, 81, 47; 3. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 208, 392, 109, 45, 1953, 1471, 1551, 485, 152, 928, 501, 90, 1435, 81, 939, 160, 472, 1349, 439, 1958, 1525, 72, 1187, 912, 368, 328A, 37, 1286, 1223, 487, 1061, 833, 688, 317, 157, 639, 375, 420, 225, 1338, 614, 214, 230, 736, 64, 1090, 1094, 1932, 1531, 421, 984, 373, 313, 918, 602, 374, 750, 1934, 1751, 1661, 961, 791, 454, 868, 416, 1329, 241; 4. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)921, (01)00884838059030(21)1440, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1428, (01)00884838059030(21)1396, (01)00884838059030(21)298, (01)00884838059030(21)1432, (01)00884838059030(21)1425, (01)00884838059030(21)1398, (01)00884838059030(21)1397, (01)00884838059030(21)1391, (01)00884838059030(21)1395, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)946, (01)00884838059030(21)1424, (01)00884838059030(21)1244, (01)00884838059030(21)1122, (01)00884838059030(21)1198, (01)00884838059030(21)1421, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)697, (01)00884838059030(21)1192, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)1148, (01)00884838059030(21)1439, (01)00884838059030(21)1431, (01)00884838059030(21)1404, (01)00884838059030(21)1140, (01)00884838059030(21)1429, (01)00884838059030(21)1430, (01)00884838059030(21)1403, (01)00884838059030(21)1393, (01)00884838059030(21)1402, (01)00884838059030(21)406, (01)00884838059030(21)71, (01)00884838059030(21)1434, (01)00884838059030(21)1392, (01)00884838059030(21)1379, (01)00884838059030(21)1401, (01)00884838059030(21)1197, (01)00884838059030(21)1435, (01)00884838059030(21)1346, (01)00884838059030(21)232, (01)00884838059030(21)231, (01)00884838059030(21)248, (01)00884838059030(21)1137, (01)00884838059030(21)1446, (01)00884838059030(21)1422, (01)00884838059030(21)1433, (01)00884838059030(21)1131, (01)00884838059030(21)1218; 5. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)1052, (01)00884838054189(21)1051, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)1072, (01)00884838054189(21)796, (01)00884838054189(21)1248, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)969, (01)00884838054189(21)1246, (01)00884838054189(21)877, (01)00884838054189(21)843, (01)00884838054189(21)1231, (01)00884838054189(21)1038, (01)00884838054189(21)1287, (01)00884838054189(21)878, (01)00884838054189(21)558, (01)00884838054189(21)633, (01)00884838054189(21)1050, (01)00884838054189(21)1000, (01)00884838054189(21)909, (01)00884838054189(21)841, (01)00884838054189(21)713, (01)00884838054189(21)731, (01)00884838054189(21)646, (01)00884838054189(21)728, (01)00884838054189(21)765, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)774, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)627, (01)00884838054189(21)604, (01)00884838054189(21)716, (01)00884838054189(21)1182, (01)00884838054189(21)965, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)694, (01)00884838054189(21)838, (01)00884838054189(21)973, (01

Risk classification

Class II

Area (FDA)

device

Country

Netherlands