Powerheart, CardioVive, Nihon Kohden and/or Responder AED 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiac Science Corporation 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
    53608
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1424-2010
  • 사례 시작날짜
    2009-10-12
  • 사례 출판 날짜
    2010-04-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-02-13
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • 원인
    Certain models of powerheart g3 aeds may not have received adequate electrical safety testing prior to being shipped from the factory. affected models are: powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, cardiovive 92532, 92533, nk 9200g, 9231, and responder 2019198 and 2023440. the affected devices were manufactured between october 29, 2003 and february 10, 2009.
  • 조치
    Cardiac Science issued "Urgent - Medical Device Corrective Action" notices dated October 2009. Customers were instructed to identify the affected product and arrange for product replacement with the firm. Where possible, end user information was requested for further follow-up by the firm. For further information, contact Cardiac Science at 1-877-402-4599 or by email at AED155@cardiacscience. com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 331104, 331604, 337397, 337878, 339693, 340376, 341871, 342086, 344846, 345416, 345909, 346118, 352290, 355192, 358479, 361455, 361573, 362241, 363055, 363268, 363491, 363662, 364586, 370323, 371556, 378795, 387103, 390455, 902084, 4001786, 4002442, 4006599, 4006773, 4008380, 4009395, 4017448, 4029897, 4030020, 4031719, 4035141, 4037678, 4038609, 4038631, 4039224, 4039431, 4039467, 4039645, 4039672, 4039807, 4040185, 4040577, 4040749, 4040833, 4041493, 4041535, 4041684, 4042176, 4042279, 4042808, 4043020, 4043292, 4044056, 4044528, 4044602, 4044862, 4045071, 4045087, 4045252, 4045536, 4045614, 4046271, 4046456, 4046647, 4047057, 4047176, 4047282, 4047283, 4047743, 4048352, 4048662, 4048730, 4048741, 4048941, 4100095, 4101486, 4102240, 4102554, 4102687, 4102872, 4103794, 4104098, 4104101, 4104118, 4104164, 4104492, 4104507, 4104622, 4104660, 4104970, 4105065, 4105091, 4105230, 4105549, 4105836, 4106271, 4106382, 4106588, 4106694, 4106729, 4107001, 4107262, 4107491, 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4220743, 4221053, 4221202, 4221522, 4221644, 4221934, 4221996, 4222205, 4222411, 4222554, 4222581, 4222582, 4222681, 4222883, 4222950, 4222963, 4223039, 4223054, 4223107, 4223664, 4223848, 4224027, 4224121, 4224152, 4224686, 4225092, 4225353, 4225545, 4225622, 4226025, 4226061, 4226121, 4226256, 4226310, 4226324, 4226462, 4226652, 4226719, 4226895, 4227193, 4227213, 4227469, 4227526, 4227549, 4227660, 4227769, 4227823, 4227824, 4227863, 4227903, 4228076, 4228113, 4228391, 4228656, 4228830, 4228862, 4228875, 4228892, 4229027, 4229070, 4229208, 4229485, 4229512, 4229529, 4229589, 4229648, 4229820, 4229939, 4230005, 4230129, 4230770, 4230985, 4231016, 4231074, 4231217, 4231627, 4231728, 4231793, 4231810, 4231875, 4231918, 4232144, 4232345, 4232426, 4232464, 4232517, 4232538, 4232558, 4232670, 4232671, 4232806, 4232914, 4232944, 4233153, 4233607, 4234032, 4234432, 4234739, 4234787, 4234800, 4236149, 4236181, 4236259, 4236319, 4236567, 4236753, 4236759, 4236805, 4236883, 4237341, 4237486, 4237490, 4237582, 4237595, 4237672, 4237714, 4237859, 4237983, 4240118, 4240204, 4240544, 4240707, 4242546, 4242592, 4243602, 4243627, 4244211, 4244258, 4244262, 4244279, 4244303, 4244432, 4244538, 4244746, 4244817, 4245198, 4245301, 4245487, 4245607, 4246012, 4246013, 4246030, 4246096, 4246395, 4246529, 4246533, 4246573, 4246620, 4246896, 4247013, 4247029, 4247036, 4247205, 4247256, 4247399, 4247461, 4247607, 4247679, 4247681, 4247687, 4247933, 4248178, 4248570, 4248629, 4248996, 4249504, 4249511, 4249535, 4250443, 4250521, 4250550, 4250919, 4250937, 4250983, 4251443, 4252619, 4252668, 4253145, 4211109ppc, 4221006ppc, 4221940ppc, 4227360ppc, 4227446ppc, 4230124ppc, 4230260ppc, 4238396ppc, 4239157ppc, and 4243424ppc.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Distributed to the United States, Australia, Belgium, Canada, Chile, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Marshall Islands, Nigeria, Norway, Philippines, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom.
  • 제품 설명
    Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and 2023440. Cardiac Science, Bothell, WA 98021. || Indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • 제조사 모회사 (2017)
  • Source
    USFDA