FDAFDA · Food and drugs·Recall number Z-2040-2012
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.
Published August 1, 2012 · Recall initiated: November 20, 2006
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- Worldwide Distribution
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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