Belos DRT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biotronik 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
    27417
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0073-04
  • 사례 출판 날짜
    2003-10-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2005-02-28
  • 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
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • 원인
    Potential extended charge time anomalies.
  • 조치
    Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up with affected patients.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 79640026, 79640028, 79640030, 79640031, 79640032, 79640033, 79640035, 79640037, 79640039, 79640044, 79640048, 79640049, 79640053, 79640058, 79640060, 79640062, 79640064, 79640065, 79640070, 79640078, 79640079, 79640080, 79640081, 79640082, 79640085, 79640086, 79640087, 79640088, 79640089, 79640091, 79640093, 79640094, 79640095, 79640097, 79640104, 79640116, 79640117, 79640121, 79640239, 79640247, 79640252, 79640323, 79640324.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributes to physicians located throughout the US.
  • 제품 설명
    Belos DR-T Implantable Cardioverter Defibrillator
  • Manufacturer

Manufacturer

  • 제조사 주소
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA