PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 23, 2025 Initiated: March 6, 2025 #Z-1555-2025

Product Description

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

Reason for Recall

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

Details

Recalling Firm
GE Medical Systems, LLC
Units Affected
12,808 total devices
Distribution
Worldwide - US Nationwide distribution.
Location
Waukesha, WI

Frequently Asked Questions

What product 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. Recalled by GE Medical Systems, LLC. Units affected: 12,808 total devices.
Why was this product recalled? ▼
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Moderate. Recall number: Z-1555-2025.

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