Events

ADVIA Centaur and ADVIA Centaur XP 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty 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-2015-RN-01135-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01135-1
  • 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
    A potential vacuum leak may occur around the glass rod sensor in the waste reservoir, caused by the gasket on the housing of the glass rod sensor sliding out of position. if the error occurs, the analyser will alarm and no results will be generated.
  • 조치
    Siemens is advising users to inspect the gasket under the Glass Rod Sensor if an error code due to low vacuum is displayed, and contact Siemens Technical Support for a replacement gasket if required. Siemens will be inspecting the Glass Rod Sensor on all analysers during the next service visit to replace if necessary. Siemens recommends discussing this notification with the laboratory director.

Device

ADVIA Centaur and ADVIA Centaur XP
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur and ADVIA Centaur XPSiemens Material Number: 10321568, 10329339, 10364455ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd