J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BOVIE MEDICAL CORPORATION 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
    30411
  • 사례 위험등급
    II
  • 사례 시작날짜
    2018-02-09
  • 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
    Bovie medical has become aware of an issue caused by incomplete insertion of the j-plasma handpiece cable plug into the generator receptacle. when the j-plasma handpiece with generator is used during surgical procedures without the cable plug being completely inserted into thgenerator the green indicator light to the left of the receptacle will illuminate event with an incomplete cable plug insertion. there have been no patient injuries reported as a result of this issue.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: BVX-330B (Lot serial: ALL); Model Catalog: BVX-270B (Lot serial: ALL); Model Catalog: BVX-330BR (Lot serial: ALL); Model Catalog: BVX-150BPP (Lot serial: ALL); Model Catalog: BVX-150B (Lot serial: ALL)
  • 제품 설명
    J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP
  • Manufacturer

Manufacturer