Z-1637-2008
INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No...
Chattanooga Corp Inc / initiated 2008-02-28 / Terminated / root cause: design
Chattanooga Corp Inc began a recall of INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2760, Chattanooga Group on . The reason FDA records is "Device may fail to administer therapy during use". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1637-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Chattanooga Corp Inc
- Product
- INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2760, Chattanooga Group.
- Product code
- IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Reason for recall
- Device may fail to administer therapy during use.
- Root cause tag
- design
- FDA root cause
- 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.
- Product codes and lots
- 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
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