Events

Retiro De Equipo (Recall) de OEC 7700 Mobile Fluoroscopy System

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 GE OEC Medical Systems, 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
    46349
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0717-2008
  • Fecha de publicación del evento
    2008-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67222
  • 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
    Mobile FluoroscopyX-Ray System - Product Code JAA
  • Causa
    Unnecessary operator exposure; x-ray machine may allow unwanted x-ray exposure to the operator.
  • Acción
    On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.

Device

OEC 7700 Mobile Fluoroscopy System
  • Modelo / Serial
    All Serial Numbers beginning with 79-, which is followed by 2006, 2008, 2009, 2011, 2013, 2014, 2015, 2016, 2018, C0513-C, C0878, C0986, C1016, C1017, C1021, C1037, C1038, C1043, C1044, C1052, C1053, C1054, C1055, C1056, C1060, C1061, C1062, C1063, C1065, C1068, C1069, C1070, C1080, C1082, C1083, C1087, C1088, C1091, C1155, C1162, C1165, C1170, C1176, C1180, C1181, C1184, C1187, C1188, C1189, C1190-M, C1192, C1193, C1195, C1196, C1197, C1198, C1199, C1201, C1203, C1204, C1207, C1208, C1209, C1210, C1212, C1213, C1214, C1216, C1219, C1236, C1238, C1241, C1246, C1248, C1249, C1254, C1255, C1259, C1260, C1263, C1265, C1266, C1269, C1271, C1272-RC, C1275, C1279, C1281, C1306, C1427, C1434, C1437, C144, C1446, C1461, C1476, C1501, C1507-M, C1511, C1529, C153, C1557, C1571, C1578, C158-RC, C1697, C1703, C1716, C1721, C1835, C1841, C1883, C189, C1903, C193, C2058, C2061, C3005, C3050, C3052a, C3053, C3055C3056, C3057, C3058, C3059, C3062, C3063, C3073, C3074, C3075, C3076, C3077, C3078, C3081, C3082, C3084, C3094, C3112, C3114, C3124, C3126, C3130, C3138, C3142, C3144, C3279, C601, C604, C605, C606-RC, C608, C609, C610, C613, C614, C616, C617, C618, C619, C620, C625, C626, C631, C633, C636, C640, C641, C647, C647-RC, C648, C651, C656, C666, C667, C669, C675, C676, C679, C680, C681, C682, C683, C684, C685, C689, C691, C692, C693, C694, C698, C699, C7084, C727, C744, C753, C774, C787, C800, C807, C808, C819, C855, C860, C863, C870, C873-RC, C878, C883-M, C886, C895-M, C904, C905, C906, C907-M, C911, C913, C916, C917-M, C922, C923-M, C926, C927, C928, C930, C933, C937, C938, C942, C943, C948, C949, C953-C, C953-M, C954, C955, C957-M, C970-M, C976, C982, C986, C987, S0607, S0970M, S1000, S1001, S1020, S1024, S1058, S1059, S1071, S1077, S1078, S1098, S1108, S1145, S1169-M, S1221-M, S1287, S1322, S1497, S1545, S1581, S1686, S271, S300, S418, S605, S615, S621, S622, S627, S628, S629, S630, S632, S634, S635, S637, S638, S639, S643, S644, S645, S646, S649, S649a, S650, S652, S653, S655, S657, S658, S659, S660, S661, S662, S663, S664, S668, S670, S671, S672, S674, S676, S677, S678, S686, S687, S696, S699, S700, S705, S732, S738, S746, S748, S766, S773, S779S766-RC, S791, S792, S798, S805-RC, S806, S814, S815, S816, S817, S818, S823, S824, S825, S829, S831, S838, S843, S845, S846, S846-M, S853, S854, S858, S859, S862, S863, S865-M, S867, S869, S874, S875, S879, S882, S884, S885-M, S891, S896, S900, S901, S901-M, S959, S964, S965, S969, S981, S988, S992, and S997.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.
  • Descripción del producto
    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Dirección del fabricante
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA