The Recall Desk

FDA (Devices) recall action 96538

GE Medical Systems, LLC recalled 2 products on 2025-04-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-04-23
Critical
0
Units
25,616

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2025-04-23

    GE Venue Fit ultrasound systems battery fire hazard recall

    GE Medical Systems is recalling certain Venue Fit ultrasound systems because the battery can develop an internal failure that could result in smoke or fire.

    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 Intervent
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    GE Venue Go Ultrasound Systems Battery Risk Recall

    GE Medical Systems is recalling certain Venue Go ultrasound system models worldwide due to potential battery internal failure that could result in smoke or fire.

    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
    Category
    Distribution
    0 states