| TGA Action ID |
RC-2026-RN-00612-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Portrait Core Services Software version V1.0.5, V1.1 and V1.2
Reference numbers: 5700209, 5697353, 5700592, 5700225 |
| ARTG Number |
396691 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware that during a service event to update Portrait Core Services software at a facility, patients who are monitored on Portrait Mobile devices can be discharged from the Portrait monitoring system. This condition can result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
Customers are to:
- Continue to use the Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2.
- Ensure appropriate alternative monitoring is established for patients before a software update is started.
- Review the User Manual addendum that includes specific instructions related to alternative monitoring during service and maintenance.
- Place a copy of the addendum with the User Manual for the Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2 system. |
| Action Commencement Date |
13/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service |