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-00209-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00209-1
  • 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 imris ort100 and ort300 table rotational locking mechanism may experience a failure. the ort100 rotational locking mechanism can become disengaged or unlocked while in use, which could potentially result in unintended movement of the table due to the older lock design. the ort300 rotational lock may fail to operate such that it cannot change states between locked and unlocked as a result of actuator failure due to improper adjustment of the actuator or the linkage. there have been no reports of injury as a result of this issue.
  • 조치
    Emergo is advising: - for users with ORT 100 tables: the rotational locking mechanism in all affected ORT 100 tables will be replaced with the most current design; - for users with ORT 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary.

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, 10002255ARTG Number: 276861(Emergo Asia Pacific - 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