| TGA Action ID |
RC-2026-RN-00365-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ApexPro CARESCAPE Telemetry Server v5.0 and v6.0 with CARESCAPE Central Station or CIC Pro Clinical Information Centre
Product Codes: SS, SUV, KSA
REF: 2063702-101, 2108523-01, 2108729-901, 5697603, 5697603-902, 5700026
Multiple product descriptions |
| ARTG Number |
118986 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Centre (Central Station).
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
GE HealthCare will correct all affected products, and a GE HealthCare representative will contact customers to arrange for the correction.
Pending corrections from GE HealthCare, customers can continue to use their ApexPro CTS with Central Station for telemetry only or combination monitoring unless you observe a persistent (more than a few seconds) NO COMM or OFF NETWORK notification.
Further instructions if customers observe a persistent NO COMM or OFF NETWORK notification are contained in the customer letter. |
| Action Commencement Date |
14/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service |