QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 PHYSIO-CONTROL CANADA SALES LTD 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
    120764
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-02-04
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Physio-control's supplier of quik-combo adult pacing/defibrillation/ecg electrodes with edge system technology and redi-pak preconnect system is voluntarily recalling specific production lots. the defibrillation electrodes are used in conjunction with certain physio-control lifepak products. this voluntary recall is being conducted due to a low-level potential for damage to the wire insulation during the manufacturing process of the affected lots. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy arcing of current sparking and patient and/or clinician burns.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 3202674-XXX (Lot serial: 516907); Model Catalog: 3202674-XXX (Lot serial: 519815); Model Catalog: 3202674-XXX (Lot serial: 519816)
  • 제품 설명
    PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM;Quik-Combo pacing/defibrillation/ECG electordes with EDGE System technology and REDI-PAK preconnect system
  • Manufacturer

Manufacturer

  • 제조사 주소
    HAMILTON
  • 제조사 모회사 (2017)
  • Source
    HC