FDA recall Z-1555-2025

GE Medical Systems, LLC · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-03-06
Report date: 2025-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1555-2025