| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00162-1 |
| Product Name/Description |
Edwards Lifesciences Heart Reference Sensor
Model Number: EVHRS
ARTG Number: 219809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Edwards Lifesciences has identified that during setup the Heart Reference Sensor (HRS) may display the error message “HRS: Out of Range” when the HRS system will not zero. This could prevent patient monitoring with the patient’s haemodynamic status using the ClearSight non-invasive system. |
| Recall Action |
Recall |
| Recall Action Instructions |
If an 'HRS: Out of Range' message is displayed customers are requested to contact Edwards Lifesciences for a replacement device. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 222 601 - Edwards Customer Service |