The Recall Desk
ModerateFDA (Devices)·Z-0521-2022·Announced 2022-02-02

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.

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: 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
Category
Medical Device — Portable Ultrasound System
Hazard

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

Distributed in 50 states:

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

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Same hazard · battery depletion

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