Events

Recall of SONARA SYSTEM - BILATERAL MAIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NATUS NEUROLOGY INCORPORATED.

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
    17439
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-20
  • 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
    Various forms of system lockup or display screen "freezes" can occur surgical monitoring has a remote probability that a lockup could cause any permanent impairment of the body function or permanent damage to a body structure.

Device

SONARA SYSTEM - BILATERAL MAIN
  • Model / Serial
    Model Catalog: 982A0470 (Lot serial: PWH0201)
  • Product Description
    SONARA TRANSCRANIAL DOPPLER SYSTEM
  • Manufacturer
    NATUS NEUROLOGY INCORPORATED

Manufacturer

NATUS NEUROLOGY INCORPORATED