Recall Z-1556-2025— GE Medical Systems, LLC

Name: FDA recall Z-1556-2025
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 3 FDA 510(k) clearances: K234106, K220848, K203137. Product: 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. 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

3 on FDA's record

K234106 — Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2024-06-10
K220848 — Venue FitGE Medical Systems·cleared 2022-06-27
K203137 — Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2020-12-29

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 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

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.