Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine System) 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-2013-RN-01062-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-14
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Contact between the detector and the patient's elbow may occur during spect protocols using 45 degree angular steps in scenarios when a patient's arms are positioned above the head and when dedicated safety armbands are not utilised.
  • 조치
    GE Healthcare is advising users to ensure the patient and the patient's extremities are not protruding beyond the table limits. GE is advising that if the patient's arms need to be extended above their head, to use the provided armbands. A software update will be provided by GE by February 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
    Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine System)ARTG Number: 200439
  • Manufacturer

Manufacturer