Events

Recall of V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    90376
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The v60 ventilator with version 2.20 software installed may falsely detect that the blower motor has stalled. if this condition occurs the software will cause the ventilator to shut down (vent inop) and display error code 100e. ventilatory support will cease. an audible high-priority alarm will sound continuously for at least 2 minutes when the v60 shuts down for any vent inop condition and is operating on battery power. if the v60 is connected to ac power (mains supply) the alarm will continue to sound until an operator intervenes. if the v60 is connected to a remote alarm system the alarm system will be activated until action is taken by the operator. error code 100e only exists in v60 version 2.20 software. therefore v60's running version 2.10 software are not subject to this particular vent inop condition. an audible high-priority alarm will sound continuously for at least 2 minutes when the v60 shuts down for any vent inop condition and is operating on battery power. if the v60 is connected to ac power (mains supply) the alarm will continue to sound until an operator intervenes. if the v60 is connected to a remote alarm system the alarm system will be activated until action is taken by the operator. error code 100e only exists in v60 version 2.20 software. therefore v60's running version 2.10 software are not subject to this particular vent inop condition.

Device

V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS
  • Model / Serial
    Model Catalog: 1053614 (Lot serial: ALL)
  • Product Description
    V60 VENTILATOR SYMBOLS ONLY WITH CFLEX AND AVAPS OPTIONS
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC