# FDA recall Z-1839-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-05-21.

## 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 Sector DICOM, Model Number H41212ZD;      e. Vscan Extend Sector USB, Model Number H41212RR;      f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC     Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It s pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitor

## Reason for recall

Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.

## Distribution

Worldwide distribution - US nationwide distributed in the states of CA, FL, IL, MA , MD, MI, MN, NY, SC, TX, UT.  Countries of Australia, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Korea (Republic Of), Netherlands, Romania, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-1839-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-05-21
- **Report date:** 2019-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1839-2019

## Citation

> AI Analytics. FDA recall Z-1839-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1839-2019. Source: US FDA. Licensed CC0.

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