Events

Recall of SHOEBOX AUDIOMETRY

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

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
    51184
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-16
  • 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
    During internal testing of shoebox audiometry on october 30 2017 it was identified that certain users won't be able to conduct an automated hearing test.

Device

SHOEBOX AUDIOMETRY
  • Model / Serial
    Model Catalog: SB003 (Lot serial: HQNTG8FJC6S3); Model Catalog: SB004 (Lot serial: HQNTG8FJC6S3)
  • Product Description
    SHOEBOX AUDIOMETRY
  • Manufacturer
    CLEARWATER CLINICAL LTD.

Manufacturer

CLEARWATER CLINICAL LTD.