Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00128-1 |
Product Name/Description |
T2100 and T2000 Treadmill power cords
ARTG number: 118412 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
18/02/2015 |
Responsible Entity |
|
Reason/Issue |
A GE Healthcare internal quality inspection has found that the power cord connecting directly to the T2100 and T2000 Treadmills may not have been assembled according to specifications. If the power cord was improperly assembled and a separate secondary electrical fault condition exists (e.g., a frayed extension or power cord touching the treadmill chassis), this could possibly result in an electrical shock to the patient or operator.
There have been no reported incidences of the Treadmill power cord leading to an electrical shock of a patient or operator at this time. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
GE Healthcare is instructing customers to continue to perform the routine maintenance specified in the T2100 T2000 Service Manuals. This includes the leakage tests performed after each monthly internal cleaning, as specified in the T2100 and T2000 Service Manuals. A GE Healthcare Service Representative will contact customers to arrange a correction. This action has been closed-out on 15/08/2016. |
Contact Information |
1800 659 465 - GE Healthcare National Call Centre |