Events

Kenex ceiling-suspended radiation shields and surgical lamps 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia 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-00208-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-03-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00208-1
  • 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
    Ge healthcare has become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. the pendent system was not installed per specified installation requirements. there has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.This action is an update of the product correction - rc-2014-rn-00407-1.
  • 조치
    GE Healthcare is inspecting all affected systems to verify that the Kenex suspension radiation shields and surgical lamps are properly installed. A GE representative will contact customers to arrange for the inspection. Any affected systems will be corrected. This actio has been closed-out on 03/08/2016.

Device

Kenex ceiling-suspended radiation shields and surgical lamps

Manufacturer

GE Healthcare Australia Pty Ltd