Events

Recall of SOLOWALK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAITTRONICS 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
    120196
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-08
  • 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
    Some machined components may not have been manufactured to the desired specification leading to premature failure of the device or some of its subsystems. this defect was first identified on march 3 2017.

Device

SOLOWALK
  • Model / Serial
    Model Catalog: 2.0 (Lot serial: 2.0); Model Catalog: 3.0 (Lot serial: 2.0); Model Catalog: 3.1 (Lot serial: 2.0); Model Catalog: 2.0 (Lot serial: 3.0); Model Catalog: 3.0 (Lot serial: 3.0); Model Catalog: 3.1 (Lot serial: 3.0); Model Catalog: 2.0 (Lot serial: 3.1); Model Catalog: 3.1 (Lot serial: 3.1); Model Catalog: 3.0 (Lot serial: 3.1)
  • Product Description
    Solowalk
  • Manufacturer
    GAITTRONICS INC.

Manufacturer

GAITTRONICS INC.
  • Manufacturer Address
    OTTAWA
  • Manufacturer Parent Company (2017)
    GaitTronics Inc
  • Source
    HC