Events

PenEvac 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 I C Medical Inc 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
    21266
  • 사례 시작날짜
    2017-04-04
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Diploma Healthcare Group Ltd trading as Big Green Surgical New Zealand Ltd, Bendall and Cant, Level 7, Southern Cross Building, Cnr High & Victoria Streets, Auckland 1140
  • 원인
    Reports have been received that the penevac diathermy pen has had instances of self-activation, which can potentially lead to patient and staff injury., phase 2. the manufacturer is issuing this safety alert to remind users of the importance of following the instructions for use to ensure safe use of the penevac1 electrocautery pencils.
  • 조치
    Product to be returned to supplier

Device

PenEvac
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Lot#6406, Lot#6384 and 6391
  • Manufacturer
    I C Medical Inc

Manufacturer

I C Medical Inc