FDA-Device2025-04-23Class II
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
GE Medical Systems, LLC
Hazard
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Sold states
Worldwide - US Nationwide distribution.
Affected count
12,808 total systems
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1556-2025Don't want to check this manually?
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