Events

Recall of Medrad Veris MR Vital Signs Monitor - Power cable

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-00549-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00549-1
  • 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
    Due to a latent design reliability issue there is potential for electrical shorting which can result in heating/melting of the cable jacket.
  • Action
    Imaxeon is providing additional safety instructions for end users until replacement DC power cables can be manufactured. Once completed the cables will be sent to end users along with instructions on returning the recalled cables.

Device

Medrad Veris MR Vital Signs Monitor - Power cable
  • Model / Serial
    Medrad Veris MR Vital Signs Monitor - Power cableCatalogue number: 3010556
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

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