Events

ADVANTX LCLP+ BI PLANE CARDIAC SYSTEM 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 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
    15935
  • 사례 위험등급
    II
  • 사례 시작날짜
    2008-07-31
  • 사례 국가
    Canada
  • 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
    The lcd monitor support may disengage from its arm and fall on the table. incorrect cable routing may cause the ecg monitor power cable to be damaged. potential for short circuit sparks & electric shock.

Device

ADVANTX LCLP+ BI PLANE CARDIAC SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 2168678-3 (Lot serial: 208/60218 704/20006); Model Catalog: 2124818 (Lot serial: 1103/00001); Model Catalog: S1838JK (Lot serial: 1203/00008 0304/10063); Model Catalog: S1838JK (Lot serial: 00000452849BU300000524113BU8); Model Catalog: 2124818 (Lot serial: S/N 704/20021 504/10005); Model Catalog: S18741AM (Lot serial: 0604/20097 1203/00031); Model Catalog: S18741AM (Lot serial: 00000112438VE7 00000460566BU3); Model Catalog: S18741AM (Lot serial: 1203/00030 1203/00034); Model Catalog: S18741AM (Lot serial: 0304/10068 00000469393BU3); Model Catalog: S18741AM (Lot serial: 304110070 00000536832BU1); Model Catalog: S18751AM (Lot serial: 1207/60204 507/50957); Model Catalog: S18751AM (Lot serial: 1007/61039 00000524145BU0); Model Catalog: S18751AM (Lot serial: 1007/61038 1005/40433); Model Catalog: S18751AM (Lot serial: 1005/40435); Model Catalog: S18751AM (Lot serial: 00000452927BU7 907/6010)
  • 제품 설명
    ADVANTIX LCLP+ BI PLANE CARDIAC SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)