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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk of fire or smoke from a battery defect in medical devices with potential to cause harm. Although the source text does not report any illnesses or injuries, the hazard (fire/smoke) poses a credible risk of injury and is not merely theoretical, warranting a High severity rating under FDA Class II guidance.
Plain-English summary
GE Medical Systems, LLC is recalling certain Venue Fit ultrasound systems, including R3, R4, R5, and China-specific models, due to a potential battery defect. The battery in these systems can develop an internal failure that could result in smoke or fire.
The affected systems include multiple model numbers with worldwide distribution, including nationwide distribution in the United States. A total of 12,808 systems are subject to this recall.
Customers who own affected Venue Fit ultrasound systems should contact GE Medical Systems for guidance on the battery issue and potential remediation steps. The manufacturer has issued this recall through the FDA to address the potential safety risk.
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…
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 12,808
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.
Part of a larger recall action
This product is one of 2 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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