| TGA Action ID |
RC-2025-RN-00324-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Venue Go and Venue Fit ultrasound systems
Affected Systems:
Venue Go R2 system (GTIN 00840682138840)
Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011)
Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527)
Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400)
Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503)
Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774)
Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041) |
| ARTG Number |
231240 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Update 14/04/2025: The battery for certain Venue Go and Venue Fit ultrasound systems with software versions R2, R3, R4 and R5 can potentially develop an internal failure which could result in smoke or fire.
This problem might occur with batteries that are toward the end of their useful life. This would be the result of a battery encountering a combination of factors including:
• a substantial number of charge/discharge cycles
• being held at a high state of charge for long durations
• general degradation of the battery cells due to age.
There have been no injuries reported to GE HealthCare as a result of this potential problem. |
| Instructions for Customers/Users |
Estimated time for completion: 12-December-2025
This correction requires a software update and battery replacement for affected systems, which must be performed by a GE HealthCare Field Engineer on-site. The process takes approximately one hour per system, including both the software update and battery installation.
We are committed to completing this Urgent Product Correction as swiftly as possible. However, due to the logistics involved, including the phased availability of FMI kits—expected to begin arriving in mid-April 2025—completion will require several months. Given the number of affected systems and the necessary coordination with customers to schedule on-site service, we anticipate that all units will be addressed by 12 December 2025.
In the interim, customers will be provided with clear instructions in the customer letter to ensure the safe use of the system until the correction is fully implemented. We appreciate TGA’s understanding and support in allowing us the necessary time to complete this correction effectively and without disruption to patient care.
This action has been closed out on 17/03/2026. |
| Action Commencement Date |
25/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service or your local Service Representative |