| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00259-1 |
| Product Name/Description |
T2100 Treadmill
ARTG Number: 118412 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
A 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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing work around instructions to minimise the risk of an unexpected change in speed or direction. GE will correct all affected units onsite. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |