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U.S. Department of Health and Human Services

Class 2 Device Recall INTELECT LEGEND XT

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  Class 2 Device Recall INTELECT LEGEND XT see related information
Date Initiated by Firm February 28, 2008
Date Posted August 06, 2008
Recall Status1 Terminated 3 on February 19, 2010
Recall Number Z-1637-2008
Recall Event ID 47428
510(K)Number K031077  
Product Classification electromechanical therapeutic ultrasound and powered muscle stimulation device - Product Code IMG
Product INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2760, Chattanooga Group.
Code Information Serial numbers: 1017, 1022, 1028, 1031, 1035, 1040, 1041, 1043, 1046, 1048, 1049, 1050, 1053, 1055, 1056, 1058, 1059, 1061, 1062, 1065, 1066, 1067, 1071, 1072, 1074, 1076, 1080, 1081, 1085, 1086, 1087, 1088, 1089, 1091, 1092, 1093, 1094, 1095, 1098, 1100, 1101, 1104, 1105, 1107, 1108, 1111, 1114, 1135, 1136, 1138, 1139, 1157, 1158, 1160, 1162, 1163, 1164, 1167, 1168, 1169, 1171, 1172, 1174, 1177, 1201, 1202, 1203, 1206, 1207, 1212, 1213, 1214, 1220, 1224, 1225, 1238, 1243, 1245, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1262, 1264, 1265, 1266, 1269, 1271, 1272, 1273, 1274, 1275, 1278, 1279, 1285, 1288, 1289, 1290, 1311, 1313, 1314, 1316, 1317, 1321, 1322, 1324, 1326, 1327, 1328, 1329, 1330, 1331, 1333, 1334, 1338, 1340, 1341, 1342, 1344, 1349, 1350, 1351, 1353, 1354, 1359, 1361, 1362, 1364, 1367, 1368, 1389, 1390, 1392, 1393, 1394, 1395, 1397, 1400, 1401, 1403, 1404, 1405, 1406, 1411, 1413, 1422, 1424, 1432, 1439, 1440, 1447, 1448, 1450, 1454, 1460, 1461, 1463, 1465, 1467, 1469, 1542, 1550, 1556, 1558, 1560, 1566, 1568, 1570, 1571, 1573, 1574, 1576, 1589, 1602, 1604, 1605, 1606, 1607, 1610, 1611, 1613, 1614, 1616, 1618, 1619, 1621, 1622, 1623, 1625, 1626, 1628, 1629, 1632, 1633, 1635, 1641, 1643, 1644, 1646, 1647, 1651, 1654, 1655, 1657, 1659, 1660, 1662, 1663, 1665, 1691, 1697, 1699, 1701, 1703, 1704, 1705, 1706, 1712, 1713, 1719, 1720, 1727, 1729, 1730, 1754, 1759, 1760, 1763, 1766, 1773, 1775, 1776, 1777, 1780, 1781, 1782, 1784, 1785, 1786, 1792, 1793, 1798, 1799, 1802, 1809, 1813, 1819, 1820, 1821, 1825, 1830, 1832, 1834, 1835, 1842, 1846, 1850, 1852, 1855, 1859, 1861, 1865, 1907, 1909, 1910, 1911, 1914, 1918, 1921, 1925, 1926, 1927, 1928, 1929, 1933, 1934, 1938, 1940, 1974, 1978, 1979, 1983, 1984, 1985, 1988, 1990, 1995, 1996, 1998, 2000, 2008, 2010, 2011, 2012, 2021, 2022, 2024, 2032, 2035, 2036, 2037, 2038, 2040, 2041, 2045, 2046, 2049, 2050, 2052, 2056, 2057, 2058, 2059, 2063, 2064, 2067, 2074, 2075, 2076, 2078, 2079, 2082, 2083, 2089, 2090, 2092, 2093, 2094, 2097, 2099, 2100, 2104, 2172, 2173, 2174, 2181, 2185, 2189, 2190, 2191, 2194, 2196, 2199, 2202, 2204, 2205, 2209, 2212, 2213, 2214, 2216, 2218, 2219, 2221, 2223, 2224, 2225, 2230, 2235, 2238, 2243, 2247, 2248, and 2282
Recalling Firm/
Manufacturer		 Chattanooga Corp Inc
4717 Adams Rd
Hixson TN 37343
For Additional Information Contact Mr. Ben Whalen
423-648-4945
Manufacturer Reason
for Recall		 Device may fail to administer therapy during use.
FDA Determined
Cause 2		 Component design/selection
Action Chattanooga Group sent an Urgent Medical Device Recall letter dated 02/29/2008 to consignees to advise them of problem and the recall. The first group of letters was sent to the distributors via certified mail. The letter stated that the devices were failing and the recall was to the User level. The firm is recalling the devices for repair and calibration. The firm followed with a user notification, by US Mail not certified beginning on March 11, 2008.
Quantity in Commerce 369 devices
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IMG and Original Applicant = CHATTANOOGA GROUP
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