Events

INSTATRAK 3500 PLUS 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
    151165
  • 사례 위험등급
    III
  • 사례 시작날짜
    2011-03-30
  • 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 customer labelling for transmitter sensor cables and receiver sensor cables states that the cables can be sterilized with the sterrad sterilization system. at the initial release of these products the only sterrad method was the 100s model. sterrad has since introduced the 100nx and nx models. the transmitter sensor cable and receiver sensor cable have been validated for sterilization in the sterrad 100s sterilizer and ethylene oxide (eto) sterilizers only. these products have not been validated for use in any other sterrad sterilizer. ge oec medical systems inc. internal testing has shown the high concentration of hydrogen peroxide used in the sterrad 100nx sterilizer is not compatible with some of the materials used in the transmitter sensor cable which may result in the degradation of the material. this could lead to a sterilization issue. testing shows that the receivers are not affected by the change in sterilization.

Device

INSTATRAK 3500 PLUS SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 1007907-NAV (Lot serial: ALL); Model Catalog: 1007914-NAV (Lot serial: ALL); Model Catalog: 1001989 (Lot serial: ALL); Model Catalog: 1002008 (Lot serial: ALL); Model Catalog: 1001990 (Lot serial: ALL); Model Catalog: 1004069 (Lot serial: ALL)
  • 제품 설명
    INSTATRAK 3500 PLUS - Sensor Cables
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)