The Recall Desk
ModerateFDA (Devices)·Z-0522-2022·Announced 2022-02-02

GE Vscan Extend Ultrasound System Recalled for Battery Power Failure

GE Healthcare is recalling the Vscan Extend portable ultrasound device due to battery power failure. The device may not power on when the battery is depleted, particularly if not turned off before battery removal or when connected to a computer 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: This is a FDA Class II recall with no reported illnesses or injuries. The hazard is a functional defect in which the device fails to power on due to battery depletion. This is a reliability issue rather than a direct safety or contamination risk.

Plain-English summary

GE Healthcare is recalling the Vscan Extend portable ultrasound device (marketed as "Vscan Extend Sector DICOM") due to a power failure issue affecting approximately 1,451 units.

The device will not power on when the battery becomes depleted. This occurs when the device is not powered off prior to battery removal or when the device is connected to a computer without AC power available to maintain the battery charge.

The affected devices were distributed domestically throughout the United States and its territories, as well as internationally to numerous countries. This is a FDA Class II recall. No illnesses or injuries have been reported.

The recalled product

Product
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Manufacturer
GE Healthcare, LLC
Category
Medical Device
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)". VH200176M2 (01008406821216511120080721VH200176M2
  • H41212ZD)
  • VH150224FV (01008406821216511117040421VH150224FV
  • H41212RT)
  • VH150359UT (01008406821216511118020021VH150359UT
  • VH150510JG (01008406821216511118110021VH150510JG
  • VH150725FX (01008406821216511119031521VH150725FX
  • VH150726PL (01008406821216511119031521VH150726PL
  • VH150833LB (01008406821216511119050021VH150833LB
  • VH2004729L (01008406821216511120122221VH2004729L
  • VH200602E1 (01008406821216511121031021VH200602E1
  • VH2007327J (01008406821216511121062921VH2007327J
  • VH1504296K (01008406821216511118070021VH1504296K
  • VH2001141J (01008406821216511120010021VH2001141J
  • VH200727M4 (01008406821216511121061421VH200727M4
  • VH200416DE (01008406821216511120111221VH200416DE
  • VH1505184H (01008406821216511118120021VH1505184H
  • VH200022GP (01008406821216511119120021VH200022GP
  • VH150208XB (01008406821216511117040421VH150208XB

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

Same manufacturer · GE Healthcare, LLC

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Same hazard · power failure

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