GE Vscan Extend portable ultrasound may not power on due to battery depletion
GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer 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: FDA Class II medical device with no reported hospitalizations, injuries, or illnesses. The hazard is a functional defect where the device fails to power on if battery depletes due to improper shutdown procedure. Without reported safety risks or harm, this operational maintenance issue meets the Moderate severity criteria.
Plain-English summary
GE Healthcare is recalling certain GE Vscan Extend portable ultrasound devices because the device will not power on if the battery is allowed to deplete due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
The affected devices were distributed domestically across all 50 U.S. states, Washington D.C., and Puerto Rico. International distribution includes locations across Europe, Asia, the Middle East, Africa, and the Americas. A total of 12,526 units were reported, with 61 units of the specific Vscan Extend Sector USB model included in this recall.
Affected users are advised to ensure the device is powered off before removing the battery and to contact GE Healthcare for guidance regarding affected units.
The recalled product
- Product
- GE Vscan Extend, being sold as "Vscan Extend Sector 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 Number)". VH150315TI (01008406821216511118020021VH150315TI
- H41212RR)
- VH15019235 (01008406821216511117033021VH15019235
- VH150328FJ (01008406821216511118021321VH150328FJ
- VH1503146U (01008406821216511118020921VH1503146U
- VH1503356H (01008406821216511118021321VH1503356H
- VH150318PI (01008406821216511118020821VH150318PI
- VH2006357M (01008406821216511121031721VH2006357M
- H41212ZB)
- VH1505402S (01008406821216511118120021VH1505402S
- VH150277MA (01008406821216511117100021VH150277MA
- VH150278XK (01008406821216511119030221VH150278XK
- VH150280EN (01008406821216511117100021VH150280EN
- VH15028191 (01008406821216511117100021VH15028191
- VH150282CY (01008406821216511117100021VH150282CY
- VH150283L3 (01008406821216511117100021VH150283L3
- VH150296YP (01008406821216511118010021VH150296YP
- VH150298DQ (01008406821216511118010021VH150298DQ
- VH150299RZ (01008406821216511118010021VH150299RZ
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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