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