GE Vscan Extend Ultrasound Device May Fail to Power On
GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.
What this means for you
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 an FDA Class II recall with no reported injuries or illnesses. The hazard is a functional failure (device will not power on due to battery depletion) rather than a direct safety risk, fitting the category of precautionary recalls without reported harm.
Plain-English summary
The Vscan Extend portable ultrasound device, sold as "Vscan Extend Dual DICOM" by GE Healthcare, LLC, is the subject of an FDA Class II recall. An estimated 9,771 units of this model are affected.
The device will not power on because of battery depletion. This occurs when the device is not turned off before the battery is removed, or when the device is connected to a computer without AC power without being properly powered down first. This power failure prevents users from operating the device.
The affected devices have been distributed domestically throughout the United States and Puerto Rico, and internationally across more than 90 countries. Individuals and healthcare facilities should review the FDA recall notice for specific affected serial numbers to determine if their devices are involved.
GE Healthcare is responsible for this recall. For further information and guidance regarding affected devices, users should refer to official communications from GE Healthcare and the FDA.
The recalled product
- Product
- GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
- 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 (Model Number
- Labeling
- UDI)". VH162804HB (01008406821216511118070021VH162804HB
- H41212ZA)
- VH261412UX (01008406821216511120040021VH261412UX
- VH261635DJ (01008406821216511120040021VH261635DJ
- VH261660DH (01008406821216511120040021VH261660DH
- VH262868PS (01008406821216511120071721VH262868PS
- VH162941AB (01008406821216511118090021VH162941AB
- VH266179UH (01008406821216511121081721VH266179UH
- VH164477C1 (01008406821216511119050021VH164477C1
- VH262930DV (01008406821216511120071721VH262930DV
- VH260225R9 (01008406821216511119120021VH260225R9
- VH16105885 (01008406821216511117100021VH16105885
- H41212RN)
- VH1618109Q (01008406821216511118020021VH1618109Q
- VH1618127M (01008406821216511118020021VH1618127M
- VH162786AS (01008406821216511118072521VH162786AS
- VH163954E2 (01008406821216511119031921VH163954E2
- VH160716CP (01008406821216511117070021VH160716CP
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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