Events

Retiro De Equipo (Recall) de Device Recall INTELECT LEGEND XT

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Chattanooga Corp Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    47428
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1637-2008
  • Fecha de inicio del evento
    2008-02-28
  • Fecha de publicación del evento
    2008-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69552
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    electromechanical therapeutic ultrasound and powered muscle stimulation device - Product Code IMG
  • Causa
    Device may fail to administer therapy during use.
  • Acción
    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.

Device

Device Recall INTELECT LEGEND XT
  • Modelo / Serial
    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
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    INTELECT LEGEND XT, electromechanical therapeutic ultrasound and powered muscle stimulation device, Model No. 2760, Chattanooga Group.
  • Manufacturer
    Chattanooga Corp Inc

Manufacturer

Chattanooga Corp Inc
  • Dirección del fabricante
    Chattanooga Corp Inc, 4717 Adams Rd, Hixson TN 37343
  • Source
    USFDA