Events

Recall of NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM - FREEDOM PROCESSING UNIT

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

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
    71253
  • Event Risk Class
    III
  • Event Initiated Date
    2014-06-19
  • 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
    Device was placed on the market subsesquent to expiration of the ce certiciate. the safety or performance is not affected.

Device

NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM - FREEDOM PROCESSING UNIT
  • Model / Serial
    Model Catalog: Z43004 (Lot serial: ); Model Catalog: Z99012 (Lot serial: 5695 5009 5010); Model Catalog: Z42001 (Lot serial: ); Model Catalog: Z99012 (Lot serial: 5004 5006 5695 5009 5010); Model Catalog: Z99012 (Lot serial: 50045006)
  • Product Description
    Nucleus 24 Auditory Brainstem Implant System
  • Manufacturer
    COCHLEAR LIMITED

Manufacturer

COCHLEAR LIMITED
  • Manufacturer Address
    MACQUARIE PARK
  • Manufacturer Parent Company (2017)
    Cochlear Ltd.
  • Source
    HC