GE Healthcare, LLC: 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.

Recall number

Z-1839-2019

Recalling firm

GE Healthcare, LLC

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 monitoring, and triage.

Status

Open, Classified

Initiated

2019-05-21

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Software design

Action

GE Healthcare notified customers on about 05/21/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to discontinue use of the LVivo EF app until a correction is available and installed on the Vscan Extend. However Vscan Extend can continue to be used for all other existing cleared indications including all other Vscan Extend apps and measurements. GE Healthcare will correct all affected products at no cost. When the LVivo EF app update is available through GE Marketplace, customers will receive an email notification sent to the email address they set up during the Vscan Extend device registration process. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Quantity

119 units

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.

Lot, serial or model codes

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), VH163278ZM (Not Available), VH162142TV (Not Available), VH163485KC (Not Available), VH163031AZ (Not Available), VH163175AT (Not Available), VH162126EN (Not Available), VH163659A8 (Not Available), VH1633048M (Not Available), VH163350EC (Not Available), VH163326UE (Not Available), VH163770L1 (Not Available), VH163784LD (Not Available), VH163036JA (Not Available), VH161216M7 (Not Available), VH1620432N (01008406821216511118040021VH1620432N), H41212RN, Serial Number (UDI): VH160254IY (Not Available), VH1607044U (Not Available), VH160176N2 (Not Available), VH1600406Z (Not Available), VH160053C5 (01008406821216511117020121VH160053C5), VH160485GP (Not Available), VH160181WQ (Not Available), VH161330TM (Not Available), VH160164PH (Not Available), VH16055084 (Not Available);   b .Model Number H41212RK, Serial Number (UDI): VH160462WV (Not Available), VH16092049 (Not Available);   c. Model Numbers H41212YZ, Serial Number (UDI): VH163439U9 (Not Available), VH163527ZC (Not Available), VH163066UJ (Not Available), VH163340NW (Not Available), VH163458CU (Not Available), VH163502LY (Not Available), VH163511T8 (Not Available), VH1636016Y (Not Available), VH163755YI (Not Available), VH163691TX (Not Available), VH1637399H (Not Available), VH163746S1 (Not Available), VH163764NN (Not Available), VH163763GE (Not Available), VH163759LP (Not Available), VH163765G2 (Not Available), VH163116N7 (Not Available), VH163044T8 (Not Available), VH162988WW (Not Available), VH163374LA (Not Available), VH163398MZ (Not Available), VH163428UW (Not Available), VH163415KB (Not Available), VH163446Z5 (Not Available), VH1634671E (Not Available), VH1636924B (Not Available), VH163744SF (Not Available), VH1637439Z (Not Available), VH1637388B (Not Available), VH163747I4 (Not Available), VH163741W3 (Not Available), VH163761IM (Not Available), VH16374052 (Not Available), VH163762TT (Not Available), VH163756TX (Not Available), VH1637451Y (Not Available), VH163766TJ (Not Available), VH163461K7 (Not Available), VH1634367P (Not Available), VH163383YB (Not Available), VH163493AE (Not Available), VH163477CV (Not Available), VH163445UT (Not Available), VH163676PS (Not Available), VH163671M1 (Not Available), VH1636685E (Not Available), VH163672YP (Not Available), VH1617429V (Not Available), VH163373TQ (Not Available), VH1634495A (Not Available), VH162698PH (Not Available), VH163113IV (Not Available), VH1633366P (Not Available), VH163002F8 (Not Available), VH163093EU (Not Available), VH16313978 (Not Available), VH163450F7 (Not Available), VH163751QX (Not Available), VH1632313N (Not Available), VH163748WX (Not Available), VH163754PU (Not Available), VH163742K9 (Not Available), VH1631245M (Not Available), VH162779KK (Not Available), H41212RL, Serial Number (UDI): VH1600189D (Not Available), VH1606843M (Not Available), VH1604606U (Not Available);   d. Model Number H41212ZD, Serial Number (UDI): VH1505638R (Not Available), VH150582C6 (Not Available), VH150663J5 (Not Available), VH150553A2 (Not Available);   e. Model Number H41212RR, Serial Number (UDI): VH150282CY (Not Available);   f. Model Number H41212ZC, Serial Number (UDI): VH150657SF (Not Available)

510(k) numbers

["K161588"]

PMA numbers

not on file

Product code

IYN

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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