GE Venue Fit ultrasound systems battery fire hazard recall
GE Medical Systems is recalling Venue Fit diagnostic ultrasound systems because the battery can potentially develop an internal failure causing smoke or fire. Approximately 12,808 systems have been distributed worldwide.
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 a Class II FDA recall for diagnostic ultrasound systems with a potential fire and smoke hazard from battery failure. Although no injuries or property damage have been reported, fire represents a significant risk of harm, qualifying this as a High severity recall for a risk-of-harm product without reported incidents.
Plain-English summary
GE Medical Systems, LLC is recalling Venue Fit diagnostic ultrasound systems, including R3, R4, and R5 models and R3 variants for China (Surgery, PeriOP, Expert, Pro, Performance, and Intervention). Approximately 12,808 systems are subject to this recall.
The battery in these ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
The affected systems have been distributed worldwide, including throughout the United States.
The recalled product
- 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
- 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 (9)
- UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400)
- Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503)
- Venue Fit R3 Surgery for China (GTIN 00195278552488)
- Venue Fit R3 PeriOP for China (GTIN 00195278552501)
- Venue Fit R3 Expert for China (GTIN 00195278552402)
- Venue Fit R3 Pro for China (GTIN 00195278552419)
- Venue Fit R3 Performance for China (GTIN 00195278552440)
- Venue Fit R3 Intervention for China (GTIN 00195278552495)
- Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041)
Distribution
Distributed nationwide across the United States.
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