GE Vscan Extend Ultrasound Devices May Not Power On Due to Battery Depletion
GE Healthcare is recalling Vscan Extend portable ultrasound devices that may fail to power on due to battery depletion when the device is not turned off before battery removal or before connecting 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 device with a functional defect causing battery depletion and inability to power on. No illnesses, injuries, or property damage have been reported. The issue is a usability/design concern rather than a direct health hazard.
Plain-English summary
GE Healthcare, LLC is recalling the Vscan Extend portable ultrasound device (also sold as "Vscan Extend Dual Wi-Fi") with model numbers H41212RL and H41212YZ. The affected devices may fail to power on due to complete battery depletion.
The battery depletion occurs because the device does not power off in certain conditions: when the battery is removed without the device being turned off first, or when the device is connected to a computer without AC power. In these scenarios, the device remains powered and continues to draw down the battery until it is completely depleted, making it impossible to power on.
Approximately 1,115 units of the Vscan Extend have been distributed domestically throughout the United States and Puerto Rico, as well as internationally. Consumers are advised to ensure the device is fully powered down before removing the battery or disconnecting from AC power.
GE Healthcare is notifying customers of the recall. Users should contact GE Healthcare for instructions on proper device operation and for information about recall remediation options.
The recalled product
- Product
- GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
- 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)". VH161002TY (01008406821216511117092521VH161002TY
- H41212RL)
- VH161494JD (01008406821216511118011021VH161494JD
- VH161911LV (01008406821216511118030021VH161911LV
- VH163440GG (01008406821216511118121421VH163440GG
- H41212YZ)
- VH261421ZS (01008406821216511120040021VH261421ZS
- VH162444U2 (01008406821216511118060021VH162444U2
- VH165272MV (01008406821216511119070021VH165272MV
- VH264483KQ (01008406821216511121011921VH264483KQ
- VH261426TR (01008406821216511120040021VH261426TR
- VH260601DD (01008406821216511120030021VH260601DD
- VH260693VL (01008406821216511120030021VH260693VL
- VH261300BX (01008406821216511120030021VH261300BX
- VH262303C1 (01008406821216511120061021VH262303C1
- VH1650459M (01008406821216511119060021VH1650459M
- VH26015148 (01008406821216511119120021VH26015148
- VH260359ZY (01008406821216511120030021VH260359ZY
- VH2605125L (01008406821216511120030021VH2605125L
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.
See all 7 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · battery depletion
See all →- ModerateAllura Xper FD20 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure
FDA (Devices) · 2025-10-08
- ModerateAllura Xper CV20 X-ray systems recalled after BIOS battery halts startup
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
Similar recalls
- HighGE Healthcare Recalls Vscan Extend Ultrasound Devices Due to EF Calculation Bias
FDA (Devices) · 2019-06-26
- HighGE Vivid i Ultrasound Systems Battery Failure Recall
FDA (Devices) · 2022-12-28
- HighGE Vivid S6 Ultrasound Systems Recalled for Battery Fire Risk
FDA (Devices) · 2022-12-28
- HighUltrasound System Batteries May Fail, Emit Smoke, or Catch Fire
FDA (Devices) · 2022-12-28
- HighVivid i N ultrasound device batteries may fail, smoke, or catch fire
FDA (Devices) · 2022-12-28
- HighGE Vivid S5 Ultrasound Systems Battery Failure Fire Risk
FDA (Devices) · 2022-12-28