Reported Jun 26, 2019 · Ongoing
LVivo EF app on Vscan Extend. Sold under the following product names
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
LVivo EF app on Vscan Extend. Sold under the following product names
5 of 5 products
| Model / number | Product as published |
|---|---|
H41212RK | Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB |
| — | Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL |
H41212ZD | Vscan Extend Sector DICOM |
H41212RR | Vscan Extend Sector USB |
H41212ZC | Vscan Extend Sector Wi-Fi, 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. |
- Lot codes and dates
- 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)
65 of 65 codes
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)
- 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)
- Amount recalled
- 119 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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