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GE Medical Systems, LLC recalls Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system
Recalled April 23, 2025 · FDA recall Z-1556-2025 · GE Medical Systems
Hazard
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. · FDA Class II
Units
12,808 total systems
Sold at
Worldwide - US Nationwide distribution.
Description
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Product
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
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →