FDA Device recall Z-1839-2019
LVivo EF app on Vscan Extend
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of LVivo EF app on Vscan Extend by Ge Healthcare, citing overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1839-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-21 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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.
Reason
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
Identifiers
| code_info | a. Model Number H41212ZA, Serial Number (UDI): VH162494DA (01008406821216511118060021VH162494DA), VH162530R2 (010084068…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), |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1839-2019%22
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