Events

Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab) 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-00663-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00663-1
  • 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 is issuing an urgent recall for product correction notice for the hettich centrifuge buckets (model 4464-r) of affected hettich rotanta 46 rsc robotic and rotanta 460 robotic centrifuges. hettich, the centrifuge manufacturer is currently investigating the reason for premature bucket failures. there is the possibility that material changes may have an impact of the strength of the buckets. when the hettich centrifuge bucket fails during centrifugation, the potential exists for a delay in patient testing and the potential for movement/rotation of the centrifuge.
  • 조치
    Siemens is providing users with instructions to conduct a weekly check of centrifuge buckets for signs of cracking and replace if required. Additionally, the maximum RPM should be reduced to 3,500 rpm.

Device

Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on Strea...
  • 모델명 / 제조번호(시리얼번호)
    Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab)Model Number: 4464-RMultiple model numbers of affected centrifuges ARTG Numbers: 174699, 238361
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd