GE Venue Go Ultrasound Systems Battery Fire and Smoke Hazard Recall
GE Medical Systems is recalling Venue Go ultrasound systems due to a battery defect that could cause smoke or fire. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving potential fire and smoke hazards from battery failure in medical ultrasound devices. No injuries, hospitalizations, or deaths have been reported. Per rubric criteria, the score is High (3) because the device poses a significant risk of harm but no actual incidents have occurred.
Plain-English summary
GE Medical Systems, LLC is recalling multiple models of Venue Go diagnostic ultrasound systems. The affected models include R2, R3, R4, R5 and regional variants (Surgery, PeriOP, Expert, Pro, Performance, and Intervention models for China). Approximately 12,808 devices have been distributed worldwide, including throughout the United States.
The battery in these ultrasound systems can develop an internal failure. This failure could result in smoke or fire, creating a potential fire hazard in clinical settings where the devices are used.
Healthcare facilities and clinical operators using affected Venue Go ultrasound systems are advised to immediately cease use and contact GE Medical Systems for instructions on device replacement or repair.
No injuries or adverse events have been reported to date. Affected users should identify their devices using the model numbers and system IDs provided and contact the manufacturer immediately.
The recalled product
- 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
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- fire
- smoke
- battery-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: Venue Go R2 system (GTIN 00840682138840)
- Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011)
- Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527)
Distribution
Distributed nationwide across the United States.
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