Events

Recall of MEDRAD Veris MR Vital Signs Monitor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Imaxeon Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01312-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01312-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA