Events

MEDRAD Veris MR Vital Signs Monitor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Imaxeon 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-2013-RN-01312-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01312-1
  • 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
    Bayer healthcare has identified that the main board, p/n 301641, installed in some medrad veris mr monitors units may be faulty and could lead to unexpected shutdown of the system while in use. this would result in the loss of vital signs information from the monitor. failure of the monitor may not only result in an inability of the user to view vital signs information but this failure may also go unrecognised. this may present an increased risk to patients who required that their vital signs be monitored while undergoing an mri exam such as those who are sedated, anesthetised or who are on critical medications. thus, it is required to continually monitor the system to ensure proper functioning.
  • 조치
    For those with affected units, Imaxeon Service Representative will be in contact to schedule an appointment to come and replace the main board. Imaxeon have established a prioritisation plan for the corrections which first addresses customers who have reported the problem and those who have the most critical medical diagnostic needs

Device

MEDRAD Veris MR Vital Signs Monitor
  • 모델명 / 제조번호(시리얼번호)
    MEDRAD Veris MR Vital Signs Monitor Monitor serial numbers : 31710, 31031, 32507, 32551, 32884, 32897, 36417, 38312Monitors containing main board (P/N 3010641) lot numbers 21-39ARTG number: 118213
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    DHTGA