Events

Recall of BREEZE C4 MOBILITY SCOOTER

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

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
    96793
  • Event Risk Class
    I
  • Event Initiated Date
    2013-11-04
  • 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
    Potential scenario where an internal potentionmeter wiper could become disconnected due to extensive wear on a certain number of assembled devices. if this were to occur the device could continue to drive forward at a slow speed of 2.4 mph and the only way to stop the device would be by turning off the main ignition key.

Device

BREEZE C4 MOBILITY SCOOTER
  • Model / Serial
    Model Catalog: BREEZE C4 (Lot serial: >100 contact manufacturer); Model Catalog: BREEZE C3 (Lot serial: >100 contact manufacturer)
  • Product Classification
    Physical Medicine Devices
  • Product Description
    BREEZE C4 MOBILITY SCOOTER
  • Manufacturer
    DISTRIBUTIONS GNX INC.

Manufacturer

DISTRIBUTIONS GNX INC.
  • Manufacturer Address
    LA PRAIRIE
  • Source
    HC