| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00114-1 |
| Product Name/Description |
Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function patient monitor)
ARTG Number: 92726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Solar 8000M/i Automatic View On Alarm (AVOA) feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AVOA alarms will not automatically appear on the left side of the Solar display. In addition, the user interface menus on the discharged patient monitor will not function correctly. This may result in delayed treatment due to missed alarms that may be serious. This issue can be fixed by rebooting the Solar 8000m/i.
Parameter, waveforms and alarms associated with the patient directly connected to the Solar 8000M/i Patient Monitor are not affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that if patients are discharged from the CIC central station to discontinue use of the AVOA feature and is providing instructions to disable the feature. If patients are not discharged from the CIC central station the AVOA feature can continue to be used. This action has been closed-out on 29/01/2016.
GE Healthcare will be implementing a software upgrade for all Solar 8000i / M monitors. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |