Events

Xhibit Central Station, software version 1.1.5 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ecomed 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-01459-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01459-1
  • 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
    Reports have been received of telemetry spo2 numerics dropping off the xhibit central display when using software version 1.1.5 with connectivity to telemetry. desaturation, high, and low limit alarms work normally. this problem can occur when the xhibit central station software version 1.1.5 is used in conjunction with a telemetry receiver for purposes of remote patient monitoring.Ecomed pty ltd has not supplied any telemetry receiver medical devices to the australian hospitals that are connected to software version 1.1.5 of xhibit central station.
  • 조치
    Although there is no product affected in Australia, product correction is being undertaken by Ecomed Pty Ltd to support potential future use of telemetry functionality with the Xhibit Central System in relevant Australian hospitals. Ecomed will be contacting affected customers to perform a software update. This action has been closed-out 11/05/2017.

Device

Xhibit Central Station, software version 1.1.5
  • 모델명 / 제조번호(시리얼번호)
    Xhibit Central Station, software version 1.1.5Serial Numbers: SLA1015F00831, SLA0916F02109ARTG Number: 237776
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd