Events

G5 Mobile Receiver Manufactured between January 2016 and February 2017 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-2018-RN-00275-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00275-1
  • 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
    G5 mobile receivers manufactured between january 2016 and february 2017 may not adequately complete the power on sequence under specific conditions. specifically, when the receiver is turned on, the green loading bar on the initialization screen becomes stuck with no further progress. the user cannot clear this screen and the receiver cannot be used to track blood glucose values. this is due to a software defect affecting devices produced in the above timeframe, which renders the receiver unusable after shutting it down in a particular sequence. this is a detectable issue for users if they check the screen after turning it on. no adverse health consequences are anticipated if you make sure you have access to an alternative means of monitoring your blood glucose.
  • 조치
    Emergo is advising users to contact Australian Medical Scientific (AMSL) to obtain a replacement receiver. Supplemental instructions will be provided to users as an interim measure to prevent this issue occurring until users receiver an updated receiver.

Device

G5 Mobile Receiver Manufactured between January 2016 and February 2017
  • 모델명 / 제조번호(시리얼번호)
    G5 Mobile ReceiverManufactured between January 2016 and February 2017 ARTG Number:169241(Emergo Asia Pacific T/a Emergo Australia - Glucose monitoring system, in vivo)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia