Events

Device Recall Powerheart 9300D automated external defibrillator 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
    53827
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0767-2010
  • 사례 시작날짜
    2009-11-13
  • 사례 출판 날짜
    2010-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86618
  • 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
    Potential for devices not to deliver therapy.
  • 조치
    Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.

Device

Device Recall Powerheart 9300D automated external defibrillator
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS: 378784, 378785, 378786, 378787, 378788, 378789, 378790, 378791, 378792, 378793, 378794, 378795, 378796, 378797, 378798, 378799, 378800, 378801, 378802, 378803, 378804, 378805, 378806, 378807, 378808, 378809, 378810, 378811, 378812, 378813, 378814, 378815, 378816, 378817, 378818, 378819, 378820, 378821, 378822, 378823, 378824, 378825, 378826, 378827, 378828, 378829, 378830, 378831, 378832, 378833, 378834, 378835, 378836, 378837, 378838, 378839, 378840, 378841, 378842, 378843, 378844, 378845, 378846, 378847, 378848, 378849, 378850, 378851, 378852, 378853, 378854, 378855, 378856, 378857, 378858, 378859, 378860, 378861, 378862, 378863, 378864, 378865, 378866, 378867, 378868, 378869, 378870, 378871, 378872, 378873, 378874, 378875, 378876, 378877, 378878, 378879, 378880, 378881, 378882, 378883, 378984, 378985, 378986, 378987, 378988, 378989, 378990, 378991, 378992, 378993, 378994, 378995, 378996, 378997, 378998, 378999, 379000, 379001, 379002, 379003, 379004, 379005, 379006, 379007, 379008, 379009, 379010, 379011, 379012, 379013, 379014, 379015, 379016, 379017, 379018, 379019, 379020, 379021, 379022, 379023, 379024, 379025, 379026, 379027, 379028, 379029, 379030, 379031, 379032, 379033, 379034, 379035, 379036, 379037, 379038, 379039, 379040, 379041, 379042, 379043, 379044, 379045, 379046, 379047, 379048, 379049, 379050, 379051, 379052, 379053, 379054, 379055, 379056, 379057, 379058, 379059, 379060, 379061, 379062, 379063, 379064, 379065, 379066, 379067, 379068, 379069, 379070, 379071, 379072, 379073, 379074, 379075, 379076, 379077, 379078, 379079, 379080, 379081, 379082 and 379083.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
  • 제품 설명
    Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

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