Events

Recall of BIPAP FOCUS SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS CALIFORNIA LLC.

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
    48185
  • Event Risk Class
    II
  • Event Initiated Date
    2008-10-06
  • 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
    This corrective action is being taken to address power supply failures on some ventilators. the failures are a result of transient power surges created from disconnection or intermittent electrical connection.

Device

BIPAP FOCUS SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 1033869 (Lot serial: Manufactured bef.Mar2708)
  • Product Description
    BiPAP Focus Ventilator Power Cord
  • Manufacturer
    RESPIRONICS CALIFORNIA LLC

Manufacturer

RESPIRONICS CALIFORNIA LLC
  • Manufacturer Address
    CARLSBAD
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC