Events

Recall of NICO NON-INVASIVE CARDIAC OUTPUT MONITOR

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
    25805
  • Event Risk Class
    III
  • Event Initiated Date
    2006-09-06
  • 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
    The audio alert speaker component may fail resulting in no audible alarm during an alert. the monitor will continue to display visual alerts.

Device

NICO NON-INVASIVE CARDIAC OUTPUT MONITOR
  • Model / Serial
    Model Catalog: 9226-00 (Lot serial: SER # START WITH 138-)
  • Product Description
    Nico model 7300 Cardiopulmonary System
  • Manufacturer
    RESPIRONICS CALIFORNIA LLC

Manufacturer

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