Events

Safety Alert for V60 Non-invasive Ventilators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Respironics California Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-06-20
  • Event Date Posted
    2013-06-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130620b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: respironics v60 non-invasive ventilators the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning v60 non-invasive ventilators which is manufactured by respironics california inc., a division of philips healthcare. in the rare even a component fails due to a software issue, the following sequence of events may occur: power management board assembly vmain shorts to ground, the ventilator shuts down, the software repeatedly cycles through part of its initialisation sequence and power on self test, the alarm may not sound to indicate that ventilation therapy has ceased. the manufacturer advises user that the v60 ventilator may continue to be used in accordance with its directions for use. the manufacturer will contact 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. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00625-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2013.

Device

V60 Non-invasive Ventilators

Manufacturer

Respironics California Inc.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH