Events

IMRIS ORT100 and ORT300 Operating Room Tables 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-2018-RN-00208-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00208-1
  • 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 ort100 and ort300 tables may drift while in use, which could potentially result in unintended movement of the table. the drift occurs slowly over time and typically is not recognised until after several hours. there have been two reports of injury overseas as a result of this issue.
  • 조치
    Emergo is advising that the following corrective actions will be undertaken: · ORT100: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do no pass the drift test, a hydraulic fluid flush and filter change will be performed. · ORT300: All customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed. A drift test will also be performed.

Device

IMRIS ORT100 and ORT300 Operating Room Tables
  • 모델명 / 제조번호(시리얼번호)
    IMRIS ORT100 and ORT300 Operating Room TablesPart Numbers: 110470-000 and 114093-000Serial Numbers: 10003241 and 10002255ARTG Number: 276861Emergo Asia Pacific T/a Emergo Australia - Table, x-ray system, diagnostic, general-purpose, powered
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia