Events

GE Infinia Nuclear Medicine Systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 GE Medical Systems Functional Imaging Haifa 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
    14856
  • 사례 시작날짜
    2013-06-19
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 원인
    Following an incident at a medical centre in the united states a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 system. the cause of the incident is under investigation. users are recommended to ensure;, 1/ only qualified service personnel maintain the equipment, 2/ that preventative maintenance procedures are conducted according to the documented schedule, 3/ all users re-review the safety chapter sections of the system manual.
  • 조치
    Manufacturer to issue advice regarding use

Device

GE Infinia Nuclear Medicine Systems
  • 모델명 / 제조번호(시리얼번호)
    Model: All Infinia systems manfactured from 2003 to 2013; all VG and VG Hawkeye systems manufactured from 1996 to 2003; all Helix systems manfactured from 1992 to 1996, Affected:
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    GE Medical Systems Functional Imaging Haifa

Manufacturer

GE Medical Systems Functional Imaging Haifa