OEC 7700 Mobile Fluoroscopy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE OEC Medical Systems, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    46349
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0717-2008
  • 사례 출판 날짜
    2008-03-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-11-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Mobile FluoroscopyX-Ray System - Product Code JAA
  • 원인
    Unnecessary operator exposure; x-ray machine may allow unwanted x-ray exposure to the operator.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah
  • Manufacturer

Manufacturer

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