| TGA Action ID |
RC-2025-RN-00904-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Flex Focus, bkSpecto, bk5000, and bkActiv Ultrasound Systems with battery
Models UA1214, UA1814
Used with Flex Focus 200, 300, 400, 500, 700. 800 |
| ARTG Number |
161422 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
This lack of guidance could result in delayed battery replacement, improper handling, or continued use of degraded batteries, potentially increasing the risk of a system malfunction or in rare cases smoke or fire.
There have been no injuries reported as a result of this problem. |
| Instructions for Customers/Users |
GE HealthCare is providing updated Instructions for Use addendums and updated Service Manuals with specific instructions regarding battery safety.
Customers can continue to use their device by following the instructions outlined in the customer letter, which outlines how to download the service manual number applicable to their product.
This action has been closed out on 31/08/2026 |
| Action Commencement Date |
23/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE Healthcare |