| TGA Action ID |
RC-2026-RN-00259-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
corpuls3 Product-family (Glasgow Full Scale or HES-License installed)
Software versions: SW-REL-4.3.3, SW-REL-4.4.2, SW-REL-4.4.3
DT Product Code: CP-4200, CP-04200, CP-04201 |
| ARTG Number |
192745 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In rare cases, corpuls3 modules running software versions SW-REL-4.3.3, 4.4.2, or 4.4.3 with an optional automatic ECG interpretation licence (Glasgow Full Scale or HES) may lose an internal configuration file during boot. This occurs randomly and cannot be influenced by the user.
If this occurs, automatic ECG interpretation and associated ECG alarms (corpuls ACS) are unavailable, while basic ECG signal acquisition and display remain functional. The alarm message “Possible acute STEMI” is not affected. Additional effects may include deletion of the stored serial number, removal of STK/MTK dates, and, in the Patient Box Module, reset of the ECG licence to “Glasgow Basic”. No warning or error message is generated; the condition can only be identified via the system information menu.
This correction supersedes RC-2025-RN-00503-1 |
| Instructions for Customers/Users |
Customers are to:
- Continue using the device as intended until the software update is deployed
- Ensure the device is updated to software version SW-REL-4.4.4 when it becomes available through scheduled service or maintenance |
| Action Commencement Date |
30/04/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Customer Service |