KLEENSPEC CORDED ILLUMINATOR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 WELCH ALLYN CANADA LIMITED 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
    53008
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-09-21
  • 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
    Welch allyn has been made aware that the kleenspec 788 corded illuminator has the potential to be incorrectly connected to a commonly available ac power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. this may result in a shattered lamp bulb and a potential electric shock hazard. commonly available ac line power cords do not have an integrated wall transformer and therefore the electrical current from the outlet is fully transferred into the device. there have been no associated injuries but the misconnection can be reproduced. for example the illuminator cord connector may fit into ac power cords from common consumer equipment such as laptop computers and other medical devices that have similar power cord connector.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 78810 (Lot serial: All); Model Catalog: 78800 (Lot serial: All); Model Catalog: 73410 (Lot serial: All)
  • 제품 설명
    KleenSpec Corded Illuminator
  • Manufacturer

Manufacturer