[pending] Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG),
Pending LLM rewrite. Source: FDA_DEVICE Z-1555-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
The recalled product
- 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
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: Venue Go R2 system (GTIN 00840682138840)
- Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011)
- Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527)
Distribution
Distributed nationwide across the United States.
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