Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Venue Fit Models: R3 (Model Number H45303VFSC Recalled by GE Medical Systems, LLC Due to The battery for certain ultrasound systems can potentially...

Date: March 6, 2025
Company: GE Medical Systems, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems, LLC directly.

Affected Products

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

Quantity: 12,808 total systems

Why Was This Recalled?

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Medical Systems, LLC

GE Medical Systems, LLC has 146 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report