| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00046-1 |
| Product Name/Description |
CARESCAPE Central Station (CSCS) software version 2.0.2
All-in-one GTIN 00840682109666; Desktop GTIN 00840682109604
ARTG Number: 132673
(GE Medical Systems Australia Pty Ltd - Patient monitor, central unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of an issue with the CARESCAPE Central Station (CSCS) software version 2.0.2 units. After boot-up or system start up, CSCS V2.0.2 units may display unexpected NO COMM notifications in the Patient Multi-Viewer or Single Viewer window when the CSCS is connected to both the Mission Critical (MC) and the Information eXchange (IX) networks. If a NO COMM notification is displayed, all patient waveforms, parameter data and alarms are lost at the CSCS and patients admitted to Telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising customers who are experiencing the NO COMM safety issue to follow instructions outlined on the customer letter to restore communication between the CSCS and patient monitoring devices in the interim. GE will arrange for a software correction to resolve this issue.
This action has been closed out on 04/02/2019 |
| Contact Information |
1800 659 465 - GE National Call Centre |