Events

LiNA Xcise Laparoscopic Morcellator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GRC Surgical Pty Ltd 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
    RC-2015-RN-00119-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00119-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Grc surgical pty ltd, following recent advice and review of the instructions for use (ifu) of this device by the therapeutic goods administration (tga), is issuing a product correction to replace the ifu previously supplied with his product. the previous ifu has been identified as not containing sufficient warnings to adequately ensure safe use of the device. changes to update the ifu have been reviewed by the tga, and are in response to a tga safety advisory statement following advice by the urogynaecological devices working group on 4th august 2014 regarding the use of laparoscopic power morcellators (https://www.Tga.Gov.Au/alert/laparoscopic-power-morcellators-update-4-august-2014) .
  • 조치
    GRC Surgical Pty Ltd is requesting all the users to quarantine the devices until the existing IFU's are removed from circulation and replaced with the updated IFU. This action has been closed-out on 20/04/2017.

Device

LiNA Xcise Laparoscopic Morcellator
  • 모델명 / 제조번호(시리얼번호)
    LiNA Xcise Laparoscopic MorcellatorReference No: MOR-1515, MOR-1515-1, MOR-1515-6 ARTG Numbers: 226906 & 180377
  • Manufacturer
    GRC Surgical Pty Ltd

Manufacturer

GRC Surgical Pty Ltd
  • Source
    DHTGA