Events

Device Recall Multifunctional electrode/defibrillation electrode 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leonhard Lang Gmbh 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
    52794
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2233-2009
  • 사례 시작날짜
    2009-07-10
  • 사례 출판 날짜
    2009-09-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84021
  • 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
    Multifunctional electrodes - Product Code MKJ
  • 원인
    A potential risk was identified associated with the connectors of the defibrillation electrodes df20. it was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. in such cases increased force or some wiggling is required to insert the connector fully. a potential risk for patients exist, if (a) such a connector (b).
  • 조치
    A Leonhard Lang letter dated June 9, 2009 was sent June 6, 2009 to its customer. The letter identified the problem and the product. The letter instructed the consignee to stop using or distributing the product and to quarantine them. It also requested them to report all quantities of product that they had in stock using the attached form.

Device

Device Recall Multifunctional electrode/defibrillation electrode
  • 모델명 / 제조번호(시리얼번호)
    DF20 SKINTACT  Lot #'s 80506-0771, 80527-0776, 80628-0776, 80826-0773, 80911-0773,
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon
  • 제품 설명
    SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria. || The device is non-sterile and single use. || For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.
  • Manufacturer
    Leonhard Lang Gmbh

Manufacturer

Leonhard Lang Gmbh
  • 제조사 주소
    Leonhard Lang Gmbh, Archenweg 56, Innsbruck Austria
  • 제조사 모회사 (2017)
    Leonhard Lang Gmbh
  • Source
    USFDA