FDA Device recall Z-1555-2025
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW)…
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW)… by Ge Medical Systems, citing the battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1555-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-06 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
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 China (Model Number H45113VGSU) diagnostic ultrasound systems
Reason
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Identifiers
| code_info | UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue…UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527); Venue Go R3 Surgery for China (GTIN 00195278547866) Venue Go R3 PeriOP for China (GTIN 00195278548344) Venue Go R3 Expert for China (GTIN 00195278547262) Venue Go R3 Pro for China (GTIN 00195278547828) Venue Go R3 Performance for China (GTIN 00195278547842) Venue Go R3 Intervention for China (GTIN 00195278548061) Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774); System ID: VENGO000382 VGB002128 VGB003021 VGD000325 VGD002313 VGD000452 VGD000488 VGD002390 VGC006411 VGB002040 VGD000354 VGC000685 VGD001444 VGC006698 VGC007776 RVGC000034 RVGC000035 VGD002256 VGD002533 VGD002535 VGD002536 VGB001162 VGC007292 VGC007119 VGC006083 VGC006841 VGB001011 VGC000147 VGD001510 RVGC000559 RVGC000562 VGD000044 VGD001371 VGD001372 VGD001375 VGD001374 VGD001373 VGD001625 VGD001638 VGC000526 RVGD002184 VGD002513 VGB0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1555-2025%22
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