Venue Fit Models: R3 recalled over fire hazard

Recall date

March 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GE Medical Systems, LLC recalls Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 syste…

Recall number

Z-1556-2025

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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