Events

Recall of T2100 TREADMILL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    35510
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-10
  • 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
    Performance issue with the t2100 treadmills can cause uncontrolled walking belt motion during a stress exercise test. this motion can be seen as an unexpected slowing followed by sudden belt acceleration in either the forward or backward direction. when this occurs engaging the emergency stop button (estop) will not immediately stop the belt. rather it will coast to a stop within 35 seconds when slowing from maximum speed. the sudden change in belt speed and/or direction can result in a fall and injury to the patient.

Device

T2100 TREADMILL

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)