Events

ADVIA Centaur XPT System 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-2016-RN-00720-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00720-1
  • 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
    Siemens healthcare diagnostics has identified issues with all the advia centaur xpt system software versions that may affect the results generated by the system as described below:1. there is potential for discrepant qc and patient results. stop running the system until it is serviced if the conditions occur. the probability of this failure occurring is extremely unlikely.2. if the daily cleaning procedure (dcp) fails to complete there is potential for discrepant qc and patient results. the probability of this failure occurring is unlikely but possible if bulk fluids are not filled prior to starting the dcp.3. there is potential for delayed results noticeable to the user as either absence of results or an error posted for the sample. no erroneous results will be reported.Siemens advises the overall risk to health is low.
  • 조치
    Siemens is asking users to follow the detailed instructions in the customer letter.

Device

ADVIA Centaur XPT System
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur XPT SystemSiemens Material Number: 10711433All the ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979)ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd