GE Healthcare, LLC recalls LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212Z…

Recall date

May 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1839-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

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…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 monitoring, and triage.