Events

Essenta DR Compact (Digital diagnostic X-Ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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-2012-RN-01094-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01094-1
  • 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
    1. the weight of the u-arm on the essenta dr compacta is counterbalanced by two parallel suspension springs in the column. when a single spring breaks, there is a risk that the safety catch mechanism may not activate due to the counteracting force of the remaining spring. as a result, the u-arm moves down uncontrollably. this was observed during reliability tests on the steel rope within the vertical carriage where one of the springs broke and the safety catch did not hold. in a post market risk assessment it was detected, the item can occur in the field by 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system.2. during in house testing it was detected that the lifetime of the wire rope for the vertical movement is significantly lower than 10 years specified in the instructions for use. if the rope breaks, the safety catch will hold the u-arm under all circumstances.
  • 조치
    Philips Healthcare is replacing the vertical carriage, wire rope and Instructions for Use (IFU).

Device

Essenta DR Compact (Digital diagnostic X-Ray system)

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA