GE Vscan Extend Ultrasound Device Battery Power Failure Recall
GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall with no reported injuries or illnesses. The hazard is device malfunction where the battery may become depleted, preventing power-on. This is primarily a functionality issue rather than a direct physical or chemical safety threat.
Plain-English summary
GE Healthcare, LLC is recalling the Vscan Extend portable ultrasound device, sold as the "Vscan Extend Dual USB". The device will not power on if its battery becomes depleted when the device is not turned off prior to battery removal or when the device is connected to a computer without AC power.
Affected devices have been distributed domestically throughout all 50 United States, the District of Columbia, and Puerto Rico. The device has also been distributed internationally to numerous countries across Europe, Asia, the Middle East, Africa, South America, and other regions. Approximately 77 units of this specific model have been identified in the recall.
Consumers who own affected devices should discontinue use and contact GE Healthcare, LLC for instructions on how to address the issue. The device should not be relied upon until the issue has been resolved by the manufacturer.
The recalled product
- Product
- GE Vscan Extend, being sold as "Vscan Extend Dual USB"
- Manufacturer
- GE Healthcare, LLC
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 (20)
- Information reads "Serial Number (UDI
- Model Nubmer)". VH1602482A (01008406821216511117040721VH1602482A
- H41212RK)
- VH160398U2 (01008406821216511117040021VH160398U2
- VH160910MS (01008406821216511117090021VH160910MS
- VH160692PU (01008406821216511117060021VH160692PU
- VH16072033 (01008406821216511117060021VH16072033
- VH164639E1 (01008406821216511119060021VH164639E1
- H41212YY)
- VH165023E4 (01008406821216511119090021VH165023E4
- VH26557563 (01008406821216511121071221VH26557563
- VH265583RM (01008406821216511121070921VH265583RM
- VH2656017N (01008406821216511121070821VH2656017N
- VH265638Q4 (01008406821216511121070921VH265638Q4
- VH26564046 (01008406821216511121070921VH26564046
- VH265645Q7 (01008406821216511121070821VH265645Q7
- VH265647U2 (01008406821216511121070921VH265647U2
- VH265836ZG (01008406821216511121071221VH265836ZG
- VH265838JV (01008406821216511121071221VH265838JV
- VH265842CE (01008406821216511121071221VH265842CE
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare, 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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