Medical device recalls Moderate risk

Venue Go Models: R2 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 Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers…
Recall number
Z-1555-2025
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 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 ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems

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