Events

Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-01134-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01134-1
  • 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
    The manufacturer, fhc inc, has received two reports where the 5-hole metal insert of the frame adapter or positioner became loose. in both instances, the insert did not fall completely out of metal housing but loosened within the adapter. neither event resulted in patient injury. such looseness may result in a slight axial movement of the insert although fhc has not identified any significant patient risk as a result of this movement.
  • 조치
    Users are advised to contact Emergo Australia to arrange for the return of affected devices to the manufacturer, FHC Inc, for repair. There are loan kits available for use until the devices are corrected.

Device

Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neur...
  • 모델명 / 제조번호(시리얼번호)
    Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system)Model Numbers: 70-LG-01, 70-FA-RD, 70-FA-LXSerial Numbers: 10205, 00001, 00002, 126279, 126314ARTG Number: 177545
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia