Recall Z-1556-2025 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Medical Systems, LLC
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems
| Date | Apr 11, 2025 (initiated Mar 6, 2025) |
| Status | Open, Classified |
| Reason | The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/6/25 was sent to customers. Actions to be taken by Customer/User: You can continue to use your Venue Go and Venue Fit system after following the actions below: 1) Turn the system Off and unplug the system from the wall socket. 2) Remove the system batteries by following instructions provided in the User Manual Chapter 3. These instructions are also provided in this letter in Appendix A for Venue Go and in Appendix B for Venue Fit. 3) Check the date of manufacture of the system batteries by looking at the label on the bottom of |
| Quantity | 12,808 total systems |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |