Health product recall

T2100 Treadmill (2018-04-02)

Starting date:
April 2, 2018
Posting date:
April 24, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66546

Affected products

T2100 Treadmill

Reason

A performance issue with customer owned spare parts, T2100 Microflex Drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction (gehc ref# 30074). If these parts were installed from customer owned stock on the T2100 Treadmill, uncontrolled walking belt motion during a stress exercise test could occur. 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.

Affected products

T2100 Treadmill

Lot or serial number

Not applicable

Model or catalog number

2065453-001

Companies
Manufacturer

GE Medical Systems Information Technologies, Inc.

8200 W Tower Ave

Milwaukee

53223

Wisconsin

UNITED STATES