Events

Essenta DR X-ray System (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-2013-RN-01328-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01328-1
  • 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
    If during system installation, the screws holding the c-arm were mounted using thread locking compound (for example, loctite), then the corresponding thread inserts inside the c-arm casting may loosen when the c-arm is dismantled. if after reassembly of the system, the loosened thread inserts become detached from the casting, the c-arm would no longer securely held in position and could fall. the c-arm is most often dismantled and reassembled when the system is moved to another location.
  • 조치
    Philips Healthcare is advising users to check the connection of the C-arm to the column to ensure the C-arm is parallel to the column in side view. If the C-arm is not parallel, do not use the system and contact Philips Healthcare. Philips Healthcare is inspecting all affected units and applying a safety label on affected systems. Local service manuals will be updated at each system site.

Device

Essenta DR X-ray System (Digital diagnostic X-Ray system)
  • 모델명 / 제조번호(시리얼번호)
    Essenta DR X-ray System (Digital diagnostic X-Ray system)ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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