Events

Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific 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-2017-RN-00714-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00714-1
  • 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
    In august 2015 radiometer advised users about a potential issue (tga ref. rc-2015-rn-00805-1) where a battery module overheated caused by the continued charging of a failing battery cell. the temporary countermeasure recommended, after the battery modules below 910-311p0009nxxx had been replaced, was for the capacity of the battery module to be checked at least every 12 months following the instructions that were provided.The manufacturer has now released an upgrade of the abl90 series software to software version 3.3 or higher. this new version monitors the charge level for the battery. if one or more failing battery cells are detected, the analyser status turns yellow and message 1559 “battery error detected” appears. if message 1559 has been active for four weeks in a row, the analyser enters operator intervention required with message 1560 “battery error still detected” and the analyser is locked until the battery has either been removed or exchanged.
  • 조치
    Radiometer will contact users to arrange for the installation of the software upgrade.

Device

Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medi...
  • 모델명 / 제조번호(시리얼번호)
    Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd