The Recall Desk
HighFDA (Devices)·Z-1555-2025·Announced 2025-04-23

GE Venue Go Ultrasound Systems Battery Risk Recall

GE Medical Systems is recalling certain Venue Go ultrasound system models worldwide due to potential battery internal failure that could result in smoke or fire.

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: The hazard (smoke or fire from battery internal failure) is a risk-of-harm defect with potential for serious injury or property damage. No illnesses or injuries have been reported in the source text, so the score does not exceed 3 per the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling certain Venue Go diagnostic ultrasound systems due to a potential battery defect. The battery in affected units can develop an internal failure, which could result in smoke or fire.

The recall affects Venue Go Models R2, R3, R4, and R5, as well as R3 variants for China (Surgery, PeriOP, Expert, Pro, Performance, and Intervention versions). A total of 12,808 devices have been distributed worldwide, including throughout the US.

Users of affected systems should stop using them and contact GE Medical Systems for instructions on battery replacement or system service. The FDA classification for this recall is Class II.

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 — Diagnostic Ultrasound System
Hazard
Affected units
12,808

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.

Part of a larger recall action

This product is one of 2 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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