Events

Recall of V60 Non-invasive Ventilators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mayo Healthcare 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-00625-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00625-1
  • 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
    In the rare even a component fails due to a software issue, the following sequence of events may occur:1) power management board assembly (pmba) vmain shorts to ground,2) the ventilator shuts down,3) the software repeatedly cycles through part of its initialisation sequence and power on self test (post), the alarm may not sound to indicate that ventilation therapy has ceased.
  • Action
    The V60 ventilator may continue to be used in accordance with its directions for use. A Mayo healthcare representative will be contacting users to schedule the corrective action to upgrade the software. A loan unit will be provided to the users until the corrective action is completed.

Device

V60 Non-invasive Ventilators

Manufacturer

Mayo Healthcare Pty Ltd