Recall Z-1555-2025— GE Medical Systems, LLC

Name: FDA recall Z-1555-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-06

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-03-06. It names 4 FDA 510(k) clearances: K240053, K220800, K202233 and 1 more. 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: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-06
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

4 on FDA's record

K240053 — Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2024-06-10
K220800 — Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2022-06-21
K202233 — Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2020-11-18
K183362 — Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2019-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.