Events

Recall of V60 Non Invasive Ventilators (adult mechanical ventilator)

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-2012-RN-00930-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00930-1
  • 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
    A review of manufacturing data found that certain blower motor assemblies in the affected v60 ventilators may not meet specifications. specifically, the impeller may not be properly seated on the blower motor shaft. this could subsequently cause the blower to cease functioning which would result in the failure of the v60 ventilator to deliver therapy to the patient due to the loss of ventilation. the v60 ventilator will alert users to malfunctioning blowers through audible and visual alarms.
  • Action
    Mayo Healthcare is replacing all affected blower motors.

Device

V60 Non Invasive Ventilators (adult mechanical ventilator)
  • Model / Serial
    V60 Non Invasive Ventilators (adult mechanical ventilator)Serial Numbers: 100029455, 100030106, 100030107, 100020111, 100030112, 100030113, 100030115, 100030117, 100030118, 100030120 & 100030121ARTG Number: 134845
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd