Events

Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing dates 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-00695-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00695-1
  • 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
    On wednesday, june 5, 2013, ge healthcare became aware of an incident at a va medical centre facility in the united states. according to information available, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. ge healthcare has since determined that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident.
  • 조치
    GE recommends that users cease use of their Nuclear Medicine system until GE Healthcare can complete an inspection the affected systems. If an issue with the support mechanism fasteners is found on the affected systems, the GE Field Engineer will coordinate the replacement of impacted parts in the Gantry and ensure that the systems are operating safely. For more details, please see http://www.tga.gov.au/safety/alerts-device-nuclear-medicine-imaging-system-130709.htm .

Device

Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medic...
  • 모델명 / 제조번호(시리얼번호)
    Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing datesARTG Number: 200439
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd