Events

Zoll X Series Defibrillators with system software version 02.10.02.00 or higher 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zoll Medical Australia 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-2014-RN-00348-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00348-1
  • 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
    Zoll medical corporation has received 8 field reports where the device displayed an internal error reset required message and then entered acontinuous “system reset” loop. the device cannot be used if it is in a continuous system reset loop. zoll medical's investigation has identified a software error associated with the device's “full disclosure log.” the error may occur during specific conditions, and in particular when the full disclosure log reaches its memory capacity (150 cases) due to invalid data in the overwriting of a full disclosure log. the probability of having an event is low under normal operating conditions.
  • 조치
    Customers who are having devices with the affected software versions are advised to immediately erase the device full disclosure log per the instructions provided in the customer letters. Users should continue to erase the device log once/month (or before 150 cases are stored in the log) until the device software has been updated. To permanently mitigate the issue, a software upgrade pack will be provided to customers which is anticipated to be available by the week commencing March 24, 2014.

Device

Zoll X Series Defibrillators with system software version 02.10.02.00 or higher

Manufacturer

Zoll Medical Australia Pty Ltd