| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00155-1 |
| Product Name/Description |
Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)
Dash networked units with product codes EH, AAB, DSH, SBG, SHQ and SD0 in the serial number
Dash Port 2 units with product code SE5 in the serial number
ARTG number 92726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has identified several potential safety issues with the Dash 3000/4000/5000 patient monitors and the Dash Port 2 docking station.
The Dash 3000/4000/5000 patient monitors may encounter the following issues:
- Dash stops communicating on the Unity Network resulting in loss of monitoring at the CARESPACE CIC Pro Central Station.
- Dash displays distorted ECG waveforms in combination monitoring mode
- Dash date reverts to 1993
The Dash Port 2 stops communicating on the Unity Network resulting in loss of monitoring at the CARESPACE CIC Pro Central Station. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is developing a software correction and will provide to customers once development has been completed. In the interim end users have been requested to follow work around instructions to help mitigate the issues. Thia action has been closed out on 28/01/2016. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |