Events

IMRIS Operating Room table (ORT300) 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-2014-RN-01078-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01078-1
  • 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
    Emergo australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material due to an incident at a health care facility in the united states. one of the three pins that is used to hold the ort200 table alignment block in place on the floor of the mr suite went missing and was not accounted for by or personnel. during testing the missing pin was pulled into the magnet, damaging the image quality phantom and headrest extension. no injury or death occurred as a result of this incident.
  • 조치
    Emergo Australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material. A field engineer will be sent to the customer site to replace the pins. This action has been closed-out on 06/06/2016.

Device

IMRIS Operating Room table (ORT300)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia