Events

Recall of Mindray’s V Series Monitoring System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ulco Engineering 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-2014-RN-00148-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00148-1
  • 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
    Mindray has identified an issue with the v series monitoring system where the v dock power pins may lose spring tension potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down.
  • Action
    Mindray is replacing the V Dock power pin board with a redesigned board on site.

Device

Mindray’s V Series Monitoring System

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA