Recall Z-1555-2025 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Medical Systems, LLC
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for Chin
| 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 devices |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183362 | Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics, Jan 28, 2019 |
| K202233 | Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics, Nov 18, 2020 |
| K220800 | Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics, Jun 21, 2022 |
| K240053 | Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics, Jun 10, 2024 |