Events

Recall of HIRES 90K WITH THE HIFOCUS HELIX ELECTRODE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ADVANCED BIONICS 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
    24743
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-24
  • 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
    Latent electrical short can occur in the dielectric layer of the substrate assembly. prolonged exposure to the resulting dc voltage leakage could result in auditory nerve damage.

Device

HIRES 90K WITH THE HIFOCUS HELIX ELECTRODE
  • Model / Serial
    Model Catalog: CI-1400-02H (Lot serial: unknown); Model Catalog: CI-1400-01 (Lot serial: unknown)
  • Product Description
    HiRes 90K model CI-1400-02H
  • Manufacturer
    ADVANCED BIONICS LLC

Manufacturer

ADVANCED BIONICS LLC