Events

G-scan Brio Magnetic Resonance 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-2016-RN-00499-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00499-1
  • 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 is providing users with additional safety instructions for the safe use of the magnetic resonance system g-scan brio. if not addressed, the issue described could lead to an unsafe exam condition.A potential weakness in the foot rest and the left bed rail of the patient table has been identified. this weakness may lead to a fracture of the patient table within the foot rest and the left bed rail in certain conditions. in particular this may happen if a heavy patient applies a strong dynamic stress (bouncing stress) to that part of the table to access or descend from the bed. there is a chance of a patient falling, or patient injury to the head or back if this situation occurs. there have been no reports of injuries as a result of this issue.
  • 조치
    Emergo is providing users with work around instructions to follow to prevent the issue from occurring. The Instructions for Use (IFU) will be updated to include the additional information. This action has been closed-out on 13/10/2016.

Device

G-scan Brio Magnetic Resonance System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia