CLASS I Device recall · Reported 1 Aug 2012 · FDA Enforcement Report
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray recalled
GE OEC Medical Systems is recalling OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic. The recall was initiated on 20 Nov 2006 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2040-2012
- FDA event ID
- 62382
- Recalling firm
- GE OEC Medical Systems, Salt Lake City, UT
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Nov 2006
- FDA classified
- 24 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 20 Nov 2006 | Recall initiated by company | |
| 24 Jul 2012 | Classified by FDA | +2073 days |
| 1 Aug 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo
Product as listed by the FDA
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
Where it was distributed
Worldwide Distribution
Questions about this recall
Why was it recalled?
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo
Which lots are affected?
86-1834 , 86-1175 , 86-0238 , 86-0585 , 86-1230 , 86-1992 , 86-0184 , 86-1033 , 86-1480 , 86-1369 , 86-0579 , 86-1678 , 86-1059 , 86-0639 , 86-0389 & 86-0390 , 86-0775 , 86-0850 & 86-1703 , 86-0151 & 86-1311 , 86-1883 , 86-0048 & 86-2015 , 86-0915, 86-1626 & 86-1631 , 86-2118 , 86-0949 , 86-0937 , 86-0071 & 86-1015 , 86-0352 , 86-0527 , 86-0140 , 86-1697 , 86-0697 , 86-1162 , 86-1424 , 86-0795 , 86-0260 , 86-0077 , 86-2002 , 86-0811 , 86-2148 , 86-1582 , 86-1633 , 86-0454 , 86-0185, 86-1119 & 86-1885 , 86-0668 , 86-1026 , 86-0529 , 86-1754 , 86-0901 , 86-0228 , 86-1555 , 86-1212 , 86-1095 , 86-0997 , 86-1475 , 86-2137 , 86-0829 , 86-1737 , 86-1259 , 86-0013 , 86-1139 , 86-0058 , 86-0327 , 86-1346 , 86-0419 & 86-2047 , 86-1892 , 86-0359 & 86-1070 , 86-0331 , 86-1255 , 86-0785 , 86-1043 , 86-1854 , 86-0148 & 86-1036 , 86-0427 & 86-2068 , 86-1988 , 86-0092 , 86-1283 , 86-1955 , 86-0711 , 86-2035 , 86-2017 , 86-0770 & 86-2044 , 86-0716 , 86-0692 , 86-1610 , 86-0154 & 86-1822 , 86-1727 , 86-1209 & 86-1210 , 86-0046 , 86-1303 , 86-0468 , 86-1274 , 86-0113 , 86-0035 , 86-1481 , 86-1808 , 86-1332 , 86-0618 , 86-1860 , 86-0425 , 86-0912 , 86-0925 , 86-0306 & 86-0664 , 86-0987 , 86-2170 , 86-0308 , 86-1302 , 86-0399 , 86-1205 , 86-1615 , 86-2128 , 86-0162 , 86-0166 , 86-0105 , 86-1687 & 86-1844 , 86-0865 , 86-1045 , 86-1360 , 86-0903 , 86-1456 , 86-1213 , 86-1326 , 86-0745 , 86-0517 , 86-2140 , 86-0625 & 86-1399 , 86-0923 , 86-1319 & 86-2133 , 86-1499 , 86-1823 , 86-0401 , 86-0157 , 86-0685 , 86-0570 , 86-1446 , 86-1606 , 86-2030 , 86-0086 , 86-0075 & 86-0076 , 86-0435 , 86-1780 , 86-0247-RC , 86-1478 , 86-1894 , 86-0896 , 86-1249 , 86-0601, 86-0914 & 86-1248 , 86-1250 , 86-1836 , 86-0805, 86-0806 & 86-0972 , 86-1619 , 86-1576 , 86-0544 , 86-1886 , 86-1782 , 86-0475 , 86-0321 , 86-0511 , 86-1949 , 86-1150 , 86-1065 , 86-1614 , 86-1907 , 86-1625 , 86-0757 & 86-0786 , 86-2092 , 86-0501 , 86-2117 , 86-1879 , 86-1714 , 86-0416 , 86-1506 , 86-1732 , 86-0977 , 86-0964 , 86-1531 , 86-0994 & 86-1909 , 86-0091 , 86-0115 , 86-1154 , 86-2171 , 86-0739 , 86-1621 & 86-1721 , 86-1647 , 86-0589 , 86-1490 , 86-0485 , 86-0995 , 86-0657 , 86-0700 , 86-1620 , 86-2032 , 86-0487 & 86-0494 , 86-1343 , 86-0102 , 86-2005 , 86-0504 , 86-1178 , 86-0329 , 86-0777 & 86-1273 , 86-1187 , 86-0519 , 86-1536 , 86-1448 , 86-0572 , 86-1223 , 86-2199 , 86-1880 , 86-0827 , 86-0068, 86-0155 & 86-0239 , 86-0492 , 86-0558 & 86-1966 , 86-0347 & 86-0411 , 86-1324 , 86-0191 , 86-1166 , 86-0701 , 86-2008 , 86-1219 , 86-0737 , 86-0974 , 86-2095 , 86-1460 , 86-0381 , 86-1234 , 86-0890 , 86-0099 , 86-1420 , 86-0750 , 86-0259 , 86-1226 , 86-0204 , 86-0482 , 86-0378 , 86-2194 , 86-1293 , 86-0966 , 86-1111 , 86-1775 & 86-1965 , 86-0069 , 86-0137, 86-0428 & 86-0432 , 86-1813 , 86-0978 , 86-0609 , 86-0047 , 86-0070 , 86-1646 & 86-1838 , 86-0906 , 86-1432 , 86-1391 , 86-1431 , 86-1266 & 86-2238 , 86-2239 , 86-1375 , 86-0560 , 86-1686 , 86-1218 , 86-1308 , 86-0277 , 86-0755 & 86-1959 , 86-1179 , 86-0245 & 86-0253 , 86-2056 , 86-1151 , 86-2043 , 86-1192 & 86-1632 , 86-0840 , 86-1728 , 86-0025 , 86-1022 , 86-0871 , 86-0163 , 86-0271 , 86-1962 , 86-0153 & 86-1267 , 86-1523 & 86-1560 , 86-1611 , 86-0732 , 86-1540 , 86-1094 , 86-0573 & 86-1211 , 86-1494 , 86-0198 , 86-0388 , 86-0200 & 86-1381 , 86-2087 , 86-0981 & 86-1713 , 86-0120 , 86-1914 , 86-1972 , 86-1918 , 86-0106 , 86-1858 & 86-1889 , 86-1869 , 86-1583 , 86-1085 , 86-0020 , 86-0913 & 86-2126 , 86-0674-RC , 86-1652 , 86-0520 , 86-0131 , 86-1542 , 86-0036 , 86-0577 , 86-1544 , 86-0206 , 86-0731 , 86-2115 , 86-1056 , 86-0237 , 86-0358 , 86-0361 , 86-0870 , 86-0541 & 86-0980 , 86-1123 , 86-2193 , 86-2026 , 86-0298 , 86-0214 , 86-2011 , 86-0042 , 86-0918 , 86-0441 , 86-2147 , 86-1509 , 86-1428 & 86-2057 , 86-2077 , 86-1607 , 86-0299 , 86-0973 , 86-0583 & 86-0584 , 86-0575 , 86-0346, 86-0556 & 86-2113 , 86-2018 , 86-0552 , 86-2110 , 86-0624 , 86-0403 , 86-1443 , 86-0736 , 86-1579 & 86-1580 , 86-1029 , 86-1142 , 86-1009 , 86-2075 , 86-0804 , 86-1784 , 86-1513 , 86-0567 , 86-1807 , 86-0032 , 86-0255 , 86-1398 , 86-1067 , 86-1258 , 86-1960 , 86-2121 , 86-0832 & 86-2210 , 86-1317 , 86-0364 & 86-1565 , 86-1690 , 86-0064 , 86-1884 , 86-2165 , 86-1891 , 86-0594 , 86-1134 , 86-1068 & 86-1963 , 86-0452 , 86-0703 , 86-0790 , 86-2227 , 86-0838 , 86-1115 , 86-1099 , 86-0112 & 86-0715 , 86-1521 , 86-1736 , 86-2006 , 86-0996 , 86-1541 & 86-1812 , 86-0460 , 86-1133 , 86-0291 , 86-0720 , 86-0828 , 86-1489 , 86-0845 , 86-1849 , 86-0549, 86-0673 & 86-1575 , 86-1393 , 86-1388 , 86-2039 , 86-0695 , 86-0138 , 86-2157 , 86-0641 , 86-0443 , 86-0365 , 86-0430 , 86-0722 , 86-1113 , 86-0897 , 86-0109 & 86-1778 , 86-0173 , 86-0798 , 86-0262 , 86-1505 , 86-0917 , 86-0680 , 86-1841 , 86-1404 , 86-1217 , 86-0951 , 86-1831 , 86-0458 , 86-2119 , 86-0215, 86-1720 & 86-1920 , 86-0275 , 86-1698 , 86-1818 , 86-2187 , 86-1278 , 86-1657 , 86-0791 , 86-0478 , 86-1373 , 86-0328 , 86-0891, 86-0893 & 86-1338 , 86-0895 , 86-0894 , 86-1791 , 86-0554 , 86-1495 , 86-2101 , 86-0776 , 86-0107, 86-0167, 86-0766 & 86-1176 , 86-0121 , 86-0767 , 86-1550 , 86-2226 , 86-0424 , 86-0164 , 86-0844 , 86-0753 , 86-1125 , 86-1018 , 86-1126, 86-1268 & 86-1269 , 86-1156 , 86-0413 , 86-0282 , 86-1000 , 86-1037 , 86-0886 , 86-0406 , 86-0159 , 86-0332 , 86-0873 , 86-0586 , 86-1430 , 86-2205 , 86-0521 , 86-0348 , 86-0778 , 86-0402 , 86-0836 , 86-0887 , 86-0792 , 86-1551 , 86-2139 , 86-0085 & 86-2097 , 86-1999 , 86-0339 , 86-0864 , 86-0822 , 86-0506 , 86-0270-RC , 86-2003 , 86-1746 & 86-1749 , 86-1057 , 86-0802 , 86-0212 , 86-2122 , 86-0783 , 86-2135 , 86-0338, 86-0553, 86-0862 & 86-1900 , 86-1157 , 86-2107 , 86-1316 , 86-1627 , 86-0279 , 86-1587 , 86-0702 , 86-0935-RC , 86-1915 , 86-1368 , 86-1590 , 86-0831 , 86-0746 , 86-0257 , 86-2111 , 86-0311 , 86-0136 , 86-1702 , 86-0334 & 86-1733 , 86-0596, 86-0613, 86-0614, 86-0868 & 86-1724 , 86-0309 , 86-0921 , 86-1855 , 86-1527 , 86-1216 , 86-1385 , 86-1695 , 86-0826 , 86-1529 , 86-1515 , 86-0375 , 86-1761 & 86-1764 , 86-0616 , 86-0859 , 86-0843 , 86-1819 , 86-0263 , 86-1982 , 86-0649 , 86-0227 , 86-0742 & 86-2004 , 86-0663 , 86-1638 , 86-0170 , 86-0097 & 86-0100 , 86-1581 , 86-2168 & 86-2198 , 86-0223 , 86-0683 , 86-0201 , 86-0203 & 86-1688 , 86-0769 , 86-0156 , 86-2232 & 86-2234 , 86-0057 , 86-1201 , 86-1287 , 86-1856 , 86-1027 , 86-1772 , 86-1260 , 86-1310 , 86-0817 , 86-0984 , 86-1670 , 86-0957 , 86-0119 , 86-2203 , 86-0333 , 86-1926 , 86-1704 , 86-0067 , 86-1870 , 86-0610 , 86-0597 , 86-0171, 86-0763 & 86-0883 , 86-0030 , 86-1138 , 86-2136 , 86-0061, 86-0453, 86-1097 & 86-1357 , 86-1300 , 86-0985 , 86-1342 , 86-1304 , 86-1204 , 86-2176 & 86-2177 , 86-0867 , 86-1659 & 86-0547 , 86-1184 & 86-1487 , 86-1055 , 86-1106 , 86-0623 & 86-1693 , 86-1003 , 86-0125 , 86-2197 , 86-1636 , 86-1532 , 86-0360 , 86-1158 , 86-0869 , 86-0533 , 86-1671 , 86-0765 , 86-0310 & 86-1630 , 86-1305 , 86-1307 , 86-0369 , 86-0652 , 86-1314 , 86-1829 , 86-1155 , 86-0190 , 86-0307 , 86-1572 , 86-0513 , 86-0250 , 86-1107 , 86-1588 , 86-0486 , 86-1207 , 86-0124 , 86-0098 , 86-0193 , 86-0049 & 86-0648 , 86-1906 , 86-1277 , 86-1121 , 86-0095 , 86-1124 , 86-1117 , 86-2055 , 86-1421 & 86-1445 , 86-0861 , 86-0660 , 86-1923 , 86-1140 , 86-2222 , 86-0525 , 86-0599 , 86-1722 , 86-1779 , 86-0962 & 86-1851 , 86-1423 , 86-1806 & 86-1957 , 86-0706 , 86-1696 , 86-1866 , 86-1425 , 86-2099 , 86-1500 & 86-2207 , 86-1345 , 86-0412 , 86-0932 , 86-1561, 86-1876 & 86-1878 , 86-0684 , 86-2164 , 86-1719 , 86-0383 & 86-1589 , 86-0114 , 86-1102 , 86-0322 , 86-0983 , 86-1998 , 86-1832 , 86-0396 , 86-0342 , 86-1815 , 86-1110, 86-1933 & 86-1986 , 86-0283 , 86-1637, 86-2038 & 86-2060 , 86-1491 , 86-1108 , 86-1927 , 86-2191 & 86-2192 , 86-0080 , 86-2130 , 86-0699 & 86-1241 , 86-0374, 86-1603, 86-1604 & 86-1605 , 86-1752 , 86-1514 , 86-0074 & 86-1147 , 86-1821 , 86-1781 , 86-0251 , 86-0229 , 86-0857 , 86-0920 , 86-1974 , 86-0559 & 86-0719 , 86-0366 , 86-1001 , 86-1845 , 86-1661 , 86-1881 , 86-0122 , 86-1076 , 86-0916 & 86-1435 , 86-1052 , 86-0384, 86-0385, 86-0636 & 86-1066 , 86-0281 , 86-1379 , 86-1377 , 86-1867 , 86-0631 , 86-0417 & 86-1503 , 86-1221 , 86-1383 , 86-2209 , 86-2208 , 86-0244 , 86-0408 & 86-1562 , 86-0490 , 86-1916 & 86-1917 , 86-0910-RC , 86-0797 , 86-1047, 86-1786 & 86-1940 , 86-0545 & 86-0735 , 86-1535 , 86-1852 , 86-1622 , 86-2007 , 86-2014 , 86-0199 , 86-1941 , 86-0650 , 86-0789, 86-1612 & 86-1613 , 86-1476 , 86-1742 , 86-2146 , 86-0540 , 86-1014 , 86-0038 , 86-0420, 86-0421 & 86-1566 , 86-1069 , 86-1079, 86-1082 & 86-1098 , 86-1143 , 86-1188 , 86-1510 , 86-1112 , 86-0470 , 86-1465 , 86-1231 , 86-1041 , 86-1297 , 86-0813, 86-0880 & 86-1251 , 86-0236 , 86-0976 , 86-0855 , 86-0084 & 86-0698 , 86-1429 , 86-0093 , 86-1654 , 86-0226, 86-0979 & 86-1382 , 86-1729 , 86-0550 , 86-0264 , 86-1888 , 86-1785 , 86-0444 , 86-1252 , 86-1595 & 86-1596 , 86-2237 , 86-0542 , 86-0999 , 86-1279 , 86-1694 , 86-0415, 86-0833 & 86-0900 , 86-0841 , 86-0543 , 86-0174 , 86-1214 , 86-0219 , 86-1053 , 86-0508 , 86-0904 , 86-1093 , 86-0394 , 86-0371 , 86-0576 , 86-1196 , 86-1669 , 86-0286 , 86-2138 , 86-1634 , 86-0644 , 86-0738 , 86-0688 & 86-1790 , 86-1903 , 86-0712 , 86-1136 , 86-0955 , 86-0687 & 86-2034 , 86-1182 , 86-1286 , 86-0571 , 86-1254 , 86-0507 , 86-0045 , 86-1402 & 86-1537 , 86-0192 , 86-0370 & 86-0620 , 86-1276 , 86-0284 , 86-1450 , 86-1451 & 86-1452 , 86-1816 , 86-0637 , 86-0989 , 86-1597 , 86-0592 , 86-1890 , 86-0600 & 86-1272 , 86-1953 , 86-1993 , 86-0608 , 86-2215, 86-2216, 86-1810, 86-2000, 86-2188 & 86-2189 , 86-1864 & 86-1939 , 86-0866 , 86-1058 & 86-2083 , 86-0642 , 86-1242 , 86-2025 , 86-0988 , 86-1422 , 86-0393 , 86-0662 , 86-1987 , 86-0149 , 86-1483 , 86-0014 & 86-0017 , 86-0581, 86-0678 & 86-0679 , 86-0222 & 86-1725 , 86-1739 , 86-0040 , 86-0852 , 86-0343 , 86-0029 , 86-0691 , 86-0033 , 86-0764 , 86-1570 & 86-1574 , 86-1013 , 86-0548 , 86-0349 , 86-0462 , 86-1600 , 86-0555 , 86-0677 , 86-0605 , 86-1616 & 86-1618 , 86-0304 & 86-1677 , 86-1061 , 86-1449 , 86-0382 , 86-2229 , 86-0909 , 86-0782 & 86-2112 , 86-1454 , 86-0846 , 86-1682 , 86-1734 , 86-0380 , 86-1392 , 86-2149 , 86-2163 , 86-1240 , 86-0952 , 86-0211 & 86-0690 , 86-0647 & 86-1712 , 86-0875 , 86-1715 , 86-1372 , 86-1034 , 86-1945 , 86-0147 , 86-0761 & 86-2167 , 86-0325 , 86-2127 , 86-1904 , 86-1771 , 86-1760 & 86-1847 , 86-0655 & 86-1135 , 86-0276 , 86-0477 , 86-1011 , 86-1183 , 86-1320 , 86-0233 , 86-0320 , 86-1060 , 86-0863 , 86-0718 , 86-0231 & 86-0457 , 86-0422 , 86-0748 , 86-0078 & 86-1330 , 86-0693 , 86-0874 , 86-1050 , 86-1051 , 86-0788 , 86-0858 , 86-1679 , 86-1556 , 86-0016 & 86-1144 , 86-0150 , 86-1042 & 86-1783 , 86-1441 , 86-1077 , 86-0741 , 86-1709 , 86-1173 & 86-2103 , 86-0269 , 86-0465 , 86-0146 & 86-1376 , 86-1224 & 86-1271 , 86-0431 & 86-1768 , 86-1374 , 86-1658 , 86-1922 , 86-0986 , 86-0034 , 86-0230 , 86-1899 , 86-2028 , 86-2081 , 86-1169 , 86-0168 , 86-0704 , 86-1651 , 86-2041 , 86-0261 , 86-1924 , 86-1171 & 86-1501 , 86-0337 , 86-0953 , 86-1968 , 86-0450 , 86-1868 , 86-2230 , 86-0161 , 86-0357 , 86-0301, 86-0303 & 86-1186 , 86-0177 , 86-1983 , 86-0787 , 86-2131 , 86-1502 , 86-2067 , 86-2145 , 86-1208 , 86-1895 , 86-0669 & 86-1664 , 86-0653 , 86-0796 , 86-1012 , 86-0646 , 86-0423 & 86-2072 , 86-0397 , 86-0039 , 86-0128 , 86-2049 , 86-0178 , 86-0265 , 86-1763 , 86-2225 , 86-0931 , 86-0258 , 86-1457 , 86-1608 , 86-1081 , 86-0754 , 86-1358 , 86-0670 , 86-1396 , 86-2090 , 86-1774 , 86-1996 & 86-1997 , 86-1617 , 86-1181 , 86-1875 , 86-1717 , 86-0196 & 86-1681 , 86-0661 , 86-0825 , 86-0217 , 86-1528 , 86-0111 & 86-1517 , 86-1623 , 86-0537 , 86-1710 , 86-1261 , 86-0123 & 86-0433 , 86-0530 , 86-0116-RC , 86-0617 , 86-1141 , 86-1990 , 86-0235 , 86-1675 , 86-2061 , 86-0368 , 86-1447 , 86-2223 , 86-0793 , 86-0024 , 86-1835 , 86-1573 , 86-1039 , 86-1757 , 86-1554 , 86-0290 , 86-1306 , 86-0856 , 86-1913 , 86-0050 , 86-0946 , 86-0392, 86-1473 & 86-2042 , 86-1750 , 86-1723 , 86-0141 , 86-2098 , 86-0090 , 86-2109 , 86-1378 , 86-0445 , 86-1127 & 86-1361 , 86-1485 , 86-1078 , 86-1753 , 86-1100 , 86-0934 , 86-1969 , 86-1281 , 86-2123 , 86-2089 , 86-0336 , 86-2162 , 86-2202 , 86-0216 , 86-1486 , 86-0240 , 86-0466 , 86-1031 , 86-1648 , 86-1801 , 86-0942 , 86-1685 , 86-0129 , 86-0410 , 86-1200 , 86-1017 , 86-0768 , 86-1534 , 86-2086 , 86-0241 , 86-1301 , 86-1642 , 86-1025 , 86-0967 & 86-2022 , 86-1718 , 86-0363 & 86-1970 , 86-0289 & 86-1526 , 86-1165 , 86-1882 , 86-1132 , 86-0407 , 86-1893 , 86-0595-RC , 86-0254 & 86-1518 , 86-2040 , 86-0574 , 86-0028 , 86-1943 , 86-0096 , 86-1545 , 86-1253 , 86-0179 & 86-1461 , 86-2108 , 86-1512 , 86-1020 , 86-0249 , 86-0205 , 86-0502 , 86-1777 , 86-1474 , 86-1956 , 86-0800 , 86-1359 , 86-0635 , 86-0094 , 86-2106 , 86-1751 , 86-0654 & 86-1105 , 86-1233 , 86-0801 , 86-0892 , 86-0377 & 86-0484 , 86-1599 , 86-2220 , 86-0835 , 86-1340 , 86-1384 , 86-1951 , 86-0021 , 86-0528 & 86-0773 , 86-0051 , 86-1436 , 86-1814 , 86-1564 , 86-0062 , 86-1770 , 86-0588-RC , 86-0820 , 86-1160 , 86-1086 , 86-1048 , 86-0326 , 86-1859 , 86-1689 , 86-2033 , 86-0376 , 86-1901 , 86-1530 , 86-0524 , 86-0651 , 86-0312 , 86-0442 , 86-1023 , 86-0760 , 86-0593 , 86-1109 , 86-2012 , 86-0056 , 86-0627 , 86-1089 , 86-0340 , 86-0993 & 86-0998 , 86-0645 , 86-1504 , 86-1643 , 86-1309 , 86-1994 , 86-0902-RC , 86-1400 , 86-0752 , 86-2062 , 86-0975 , 86-1837 , 86-1180 , 86-0089 , 86-0451 , 86-1655 , 86-0073 , 86-1440 & 86-1442 , 86-0256 , 86-0330 , 86-0354 , 86-1295 , 86-1769 , 86-0954 , 86-0437 , 86-1850 & 86-2154 , 86-0418 , 86-1159 , 86-2114 , 86-0355 , 86-1862 , 86-2214 , 86-1129 , 86-0103 & 86-1394 , 86-0313 & 86-0400 , 86-0602 , 86-1232 , 86-0041 , 86-0335 , 86-1558 & 86-1563 , 86-0837 , 86-0088 , 86-2058 , 86-0707 , 86-1185 , 86-2069 , 86-0638 , 86-1280 , 86-0936 , 86-0449 & 86-0479 , 86-0234 & 86-1104 , 86-2213 , 86-0278 & 86-2212 , 86-1363 , 86-1789 , 86-0749 , 86-0152 , 86-0438 , 86-0172 & 86-1824 , 86-0072, 86-0087, 86-0434, 86-0938 & 86-1672 , 86-1758 , 86-0395 , 86-1674 , 86-0818 & 86-0819 , 86-0580 & 86-1971 , 86-2173 , 86-0022 , 86-1936 , 86-0296 , 86-0027 & 86-0812 , 86-0656 , 86-0207 , 86-1087 , 86-0183 , 86-0367 , 86-0604 , 86-0710 , 86-1049 , 86-1128 , 86-1479 , 86-1549 , 86-1755 , 86-0037 & 86-1458 , 86-0500 , 86-1275 , 86-0842 , 86-0175 , 86-0672 & 86-1327 , 86-0834 , 86-1364 , 86-0740 & 86-0965 , 86-0884 & 86-0885 , 86-1569 , 86-0830 , 86-0023 , 86-1692 , 86-0391 , 86-0118 , 86-0681 , 86-1028 , 86-0911 , 86-0982 , 86-0947 & 86-2174 , 86-0948 , 86-0682 , 86-0341 , 86-1193 , 86-1571 , 86-1322 , 86-0344 , 86-1063 , 86-0387 , 86-0619 & 86-0459 , 86-1389 , 86-1522 , 86-0079 & 86-1591 , 86-0130 , 86-0733 , 86-0958 , 86-0569 , 86-0724 , 86-0532, 86-0603 & 86-1177 , 86-1857 , 86-1592, 86-1601 & 86-1602 , 86-0436 , 86-0590 , 86-1477 , 86-1663 , 86-0694 & 86-1559 , 86-0615 , 86-1929 , 86-1825 , 86-0043 & 86-1439 , 86-1170 , 86-1773 , 86-0483 , 86-0345 , 86-0879 , 86-1318 & 86-1547 , 86-1593 , 86-0496 , 86-0509 , 86-1662 , 86-0971 , 86-1270 , 86-0243 , 86-0285 & 86-2104 , 86-1932 , 86-2102 , 86-0940 , 86-1103 , 86-1735 , 86-1942 , 86-0031 & 86-1116 , 86-0568 & 86-1337 , 86-1245 , 86-1743 , 86-2169 , 86-0467 , 86-0405 , 86-0562 , 86-1683 , 86-0629 , 86-1937 , 86-1676 , 86-1977 , 86-2124 , 86-0063 , 86-0246-RC , 86-1064 , 86-1328 , 86-2190 , 86-2027 , 86-0429 , 86-0882 , 86-1244 & 86-2175 , 86-0824 , 86-0696 & 86-2233 , 86-1482 , 86-0725 , 86-0065 , 86-1496 , 86-0232 & 86-1229 , 86-0780 , 86-1080 , 86-1054 , 86-0379 , 86-1707 & 86-1708 , 86-1594 , 86-1705 , 86-1578 , 86-1265 , 86-1024 , 86-2059 , 86-0751 , 86-1030 , 86-0248 , 86-1700 , 86-2228 , 86-2120 , 86-0762 , 86-1800 , 86-1455 , 86-0512, 86-0860 & 86-1684 , 86-1842 , 86-1313 , 86-2036 , 86-1902 , 86-0714 , 86-1291 , 86-0474 , 86-0705 & 86-0794 , 86-1538 , 86-1131 , 86-0643 , 86-0561 , 86-2009 , 86-1344 , 86-0881 , 86-0872 , 86-0019 , 86-1691 , 86-2218 , 86-1152 , 86-1492 , 86-0839 & 86-1557 , 86-1325 , 86-0591 , 86-1756 , 86-0242 , 86-1741 & 86-2088 , 86-1323 , 86-2204 , 86-0404 , 86-1497 , 86-0823 & 86-1995 , 86-0110 , 86-1865 , 86-1641 , 86-0213 , 86-1146 , 86-0426 , 86-1032 , 86-2079 , 86-0101 , 86-1964 , 86-1908 , 86-1706 , 86-2132 , 86-0456 , 86-0469, 86-0611 & 86-1887 , 86-0104 & 86-1227 , 86-0816 & 86-1228 , 86-2023 & 86-2024 , 86-0158 , 86-0582 , 86-1148 , 86-2206 , 86-2074 , 86-0734 & 86-1928 , 86-0758 & 86-0759 , 86-1362 , 86-1438 , 86-1730 , 86-0922 , 86-1312 , 86-1493 , 86-1021, 86-1161 & 86-1976 , 86-1975 , 86-0939 , 86-0060 , 86-0026, 86-0489, 86-1130 & 86-1329 , 86-1699 , 86-0165 , 86-1114 & 86-1437 , 86-1246, 86-1339 & 86-1826 , 86-1586 , 86-1759 , 86-0372 , 86-1804 , 86-0188 , 86-2096 , 86-0743 , 86-1628 , 86-2217 & 86-2221 , 86-1820 , 86-1673 , 86-1958 , 86-1084 , 86-0956 , 86-0252 & 86-1805 , 86-0526 , 86-0493 , 86-1366 , 86-1827 , 86-1853 , 86-1905 , 86-1910 , 86-1944 , 86-0963 , 86-1921 , 86-2219 , 86-1453 , 86-0686 , 86-0044 , 86-0626-RC , 86-0854 , 86-0578 , 86-0409 , 86-1367, 86-1433 & 86-1981 , 86-0495, 86-0498 & 86-1985 , 86-2076 , 86-2029 , 86-0139 , 86-1660 , 86-1846 , 86-1243 , 86-1434 , 86-0557 , 86-1650 , 86-1863 & 86-2001 , 86-2082 , 86-0774 & 86-1016 , 86-1802 , 86-1292 , 86-2020, 86-2021 & 86-2093 , 86-0108 & 86-0536 , 86-0186 , 86-1498 , 86-1083 , 86-0015-R , 86-1282 , 86-0160 , 86-0566 & 86-1843 , 86-0300 , 86-1989 , 86-1649 , 86-2129 , 86-0055 , 86-1711 , 86-1222 , 86-0781 , 86-1738 , 86-2016 , 86-0747 , 86-0676 , 86-1002 , 86-1315 , 86-1680 , 86-1787 , 86-1321 , 86-0905 & 86-1731 , 86-1896 , 86-1149 , 86-0675 , 86-2125 , 86-1744 , 86-0294, 86-2053 & 86-2054 , 86-2019 , 86-1386 & 86-1387 , 86-0455 & 86-0689 , 86-1062, 86-1198, 86-1347, 86-1484, 86-2166 & 86-2172 , 86-1256 , 86-0851 , 86-0218 & 86-0853 , 86-1459 , 86-2116 , 86-1163 & 86-1164 , 86-1035 , 86-0464, 86-1194 & 86-1195 , 86-0814 , 86-0353 , 86-1046 , 86-1828 , 86-1044 , 86-0176 , 86-2236 , 86-0505 , 86-1225 , 86-0709 , 86-1740 & 86-1950 , 86-0531 , 86-0356 , 86-0744 , 86-1911 & 86-1912 , 86-0132 , 86-0809 & 86-1553 , 86-0499 & 86-1809 , 86-0926 , 86-0471 , 86-1947 , 86-0472-RC, , 86-0018 , 86-0052 , 86-0053 , 86-0054 , 86-0059 , 86-0066 , 86-0081 , 86-0083 , 86-0126 , 86-0127 , 86-0133 , 86-0134 , 86-0135 , 86-0142 , 86-0143 , 86-0144 , 86-0145 , 86-0169 , 86-0180 , 86-0181 , 86-0187 , 86-0195 , 86-0197 , 86-0202 , 86-0208 , 86-0209 , 86-0210 , 86-0220 , 86-0221 , 86-0225 , 86-0266 , 86-0267 , 86-0268 , 86-0272 , 86-0273 , 86-0274 , 86-0280 , 86-0287 , 86-0288 , 86-0292 , 86-0293 , 86-0295 , 86-0297 , 86-0302 , 86-0305 , 86-0314 , 86-0315 , 86-0316 , 86-0317 , 86-0318 , 86-0319 , 86-0323 , 86-0324 , 86-0350 , 86-0351 , 86-0362 , 86-0373 , 86-0386 , 86-0398 , 86-0414 , 86-0439 , 86-0440 , 86-0446 , 86-0447 , 86-0448 , 86-0461 , 86-0463 , 86-0473 , 86-0476 , 86-0480 , 86-0481 , 86-0488 , 86-0491 , 86-0497 , 86-0503 , 86-0510 , 86-0514 , 86-0516 , 86-0518 , 86-0522 , 86-0523 , 86-0534 , 86-0535 , 86-0538 , 86-0539 , 86-0563 , 86-0564 , 86-0565 , 86-0587 , 86-0598 , 86-0606 , 86-0607 , 86-0612 , 86-0621 , 86-0622 , 86-0630 , 86-0632 , 86-0633 , 86-0634 , 86-0659 , 86-0665 , 86-0666 , 86-0667 , 86-0671 , 86-0708 , 86-0713 , 86-0717 , 86-0721 , 86-0723 , 86-0726 , 86-0727 , 86-0728 , 86-0729 , 86-0730 , 86-0756 , 86-0771 , 86-0772 , 86-0779 , 86-0784 , 86-0803 , 86-0807 , 86-0808 , 86-0810 , 86-0815 , 86-0821 , 86-0847 , 86-0848 , 86-0849 , 86-0876 , 86-0877 , 86-0878 , 86-0888 , 86-0889 , 86-0898 , 86-0899 , 86-0907 , 86-0908 , 86-0919 , 86-0924 , 86-0927 , 86-0928 , 86-0929 , 86-0930 , 86-0933 , 86-0941 , 86-0943 , 86-0944 , 86-0945 , 86-0950 , 86-0959 , 86-0960 , 86-0961 , 86-0968 , 86-0969 , 86-0970 , 86-0990 , 86-0991 , 86-0992 , 86-1004 , 86-1005 , 86-1006 , 86-1007 , 86-1008 , 86-1010 , 86-1019 , 86-1038 , 86-1040 , 86-1071 , 86-1072 , 86-1073 , 86-1074 , 86-1075 , 86-1088 , 86-1090 , 86-1091 , 86-1092 , 86-1096 , 86-1101 , 86-1118 , 86-1120 , 86-1122 , 86-1137 , 86-1145 , 86-1153 , 86-1168 , 86-1172 , 86-1174 , 86-1189 , 86-1190 , 86-1191 , 86-1197 , 86-1199 , 86-1202 , 86-1203 , 86-1206 , 86-1215 , 86-1220 , 86-1235 , 86-1236 , 86-1237 , 86-1238 , 86-1239 , 86-1247 , 86-1257 , 86-1262 , 86-1263 , 86-1264 , 86-1284 , 86-1285 , 86-1288 , 86-1289 , 86-1290 , 86-1294 , 86-1296 , 86-1298 , 86-1299 , 86-1333 , 86-1334 , 86-1335 , 86-1336 , 86-1341 , 86-1348 , 86-1349 , 86-1350 , 86-1351 , 86-1352 , 86-1353 , 86-1354 , 86-1355 , 86-1356 , 86-1365 , 86-1370 , 86-1371 , 86-1380 , 86-1390 , 86-1395 , 86-1397 , 86-1401 , 86-1403 , 86-1405 , 86-1406 , 86-1407 , 86-1408 , 86-1409 , 86-1410 , 86-1411 , 86-1412 , 86-1413 , 86-1414 , 86-1415 , 86-1416 , 86-1417 , 86-1418 , 86-1419 , 86-1426 , 86-1427 , 86-1444 , 86-1462 , 86-1463 , 86-1464 , 86-1466 , 86-1467 , 86-1468 , 86-1469 , 86-1470 , 86-1471 , 86-1472 , 86-1507 , 86-1508 , 86-1511 , 86-1516 , 86-1519 , 86-1520 , 86-1524 , 86-1525 , 86-1533 , 86-1543 , 86-1546 , 86-1552 , 86-1567 , 86-1568 , 86-1577 , 86-1584 , 86-1585 , 86-1598 , 86-1624 , 86-1629 , 86-1639 , 86-1644 , 86-1645 , 86-1653 , 86-1656 , 86-1665 , 86-1666 , 86-1667 , 86-1668 , 86-1716 , 86-1726 , 86-1745 , 86-1747 , 86-1748 , 86-1762 , 86-1765 , 86-1766 , 86-1767 , 86-1776 , 86-1788 , 86-1792 , 86-1793 , 86-1803 , 86-1811 , 86-1817 , 86-1833 , 86-1848 , 86-1861 , 86-1871 , 86-1872 , 86-1873 , 86-1877 , 86-1897 , 86-1898 , 86-1919 , 86-1930 , 86-1931 , 86-1934 , 86-1935 , 86-1948 , 86-1952 , 86-1961 , 86-1967 , 86-1973 , 86-1978 , 86-1979 , 86-1980 , 86-1991 , 86-2010 , 86-2013 , 86-2037 , 86-2045 , 86-2046 , 86-2048 , 86-2050 , 86-2051 , 86-2052 , 86-2063 , 86-2064 , 86-2066 , 86-2091 , 86-2094 , 86-2105 , 86-2134 , 86-2141 , 86-2142 , 86-2143 , 86-2144 , 86-2150 , 86-2151 , 86-2152 , 86-2153 , 86-2155 , 86-2156 , 86-2158 , 86-2159 , 86-2160 , 86-2161 , 86-2195 , 86-2196 , 86-2200 , 86-2201 , 86-2231 , and 86-2235.
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE OEC Medical Systems
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |