| TGA Action ID |
RC-2026-RN-00646-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Carescape Central Station (CSCS) V3.0.x
CSCS V3 MAS800 Desktop
Product Code: STU
Part Numbers: 5867474-04, 5867474-13
GTIN: 00195278343512, 00195278516367
CSCS V3 MAI800 Integrated
Product Code: STV
Part Numbers: 5867474-03
GTIN: 00195278343383 |
| ARTG Number |
132673 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware that the Carescape Central Station (CSCS) V3.0.x may not resume patient monitoring for at least 3 minutes following a system restart. This situation can arise only when the ‘Allow list database is corrupted’ message is displayed in the title bar of the CSCS prior to a system restart. In the unlikely event that this situation occurs, it can lead to a potential delay in recognition of clinically significant events.
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
- Customers are to review the actions required for continued use of the device in the Customer Letter.
- GE HealthCare will provide a User Manual addendum that provides guidance regarding the prolonged startup condition. |
| Action Commencement Date |
24/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE Healthcare |