LVivo EF app on Vscan Extend. Sold under the following recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

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…

Recalling firm

GE Healthcare, LLC

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.

Recall date

June 26, 2019

Classification

Class II

Status

Ongoing

Agency

FDA (device)