The Recall Desk
HighFDA (Devices)·Z-1839-2019·Announced 2019-06-26

GE Healthcare Recalls Vscan Extend Ultrasound Devices Due to EF Calculation Bias

GE Healthcare is recalling 119 Vscan Extend ultrasound devices because the LVivo EF app may overestimate ejection fraction values, potentially affecting clinical assessments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no hospitalizations or serious injuries are explicitly reported in the source text. The hazard involves inaccurate diagnostic data (overestimation of EF) rather than a direct physical injury mechanism.

Plain-English summary

GE Healthcare, LLC is recalling 119 units of the Vscan Extend diagnostic ultrasound imaging system. The recall involves specific model numbers including H41212ZA, H41212RN, H41212RK, H41212YZ, H41212RL, H41212ZD, H41212RR, and H41212ZC. These devices were distributed worldwide, including in the United States and various countries in Europe, Asia, and Australia.

The recall is due to an overestimation bias in the automatically calculated ejection fraction (EF) values when using the LVivo EF app on the Vscan Extend product. This software issue may result in inaccurate clinical data regarding heart function. The Vscan Extend is a general-purpose diagnostic ultrasound system used by qualified healthcare professionals for visualizing anatomical structures and fluid.

Healthcare professionals who have purchased or are using these specific units should contact GE Healthcare for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
119

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)

  • a. Model Number H41212ZA
  • Serial Number (UDI): VH162494DA (01008406821216511118060021VH162494DA)
  • VH162530R2 (01008406821216511118060021VH162530R2)
  • VH160454PQ (01008406821216511118040021VH160454PQ)
  • VH161212Z9 (01008406821216511118040021VH161212Z9)
  • VH162305WM (Not Available)
  • VH162300UE (Not Available)
  • VH163166GF (Not Available)
  • VH163170QD (Not Available)
  • VH162011PE (01008406821216511118040021VH162011PE)
  • VH163454AQ (01008406821216511118110021VH163454AQ)
  • VH161912X9 (01008406821216511118040021VH161912X9)
  • VH163489ED (01008406821216511118110021VH163489ED)
  • VH160832WB (01008406821216511118040021VH160832WB)
  • VH162896FQ (01008406821216511118100021VH162896FQ)
  • VH163307IQ (Not Available)
  • VH160748G4 (01008406821216511118040021VH160748G4)
  • VH163100A6 (Not Available)
  • VH162900GC (Not Available)
  • VH163879G6 (Not Available)

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · inaccurate diagnostic data

See all →