LVivo EF app on Vscan Extend — Class II medical device recall Z-1839-2019
Ongoing recall by GE Healthcare, LLC, reported 2019-06-26, distributed nationwide. Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the
| Recall number | Z-1839-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-05-21 |
| Classified | 2019-06-18 |
| Reported by FDA | 2019-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CN, CZ, DE, DK, FR, GB, GR, HK, HR, IE, IT, JP, KR, NL, RO, SE, TH |
| Quantity | 119 units |
| Serial numbers | H41212RL, H41212RN, VH150282CY, VH150553A2, VH1505638R, VH150582C6, VH150657SF, VH150663J5, VH1600189D, VH1600406Z, VH160053C5, VH160164PH, VH160176N2, VH160181WQ, VH160254IY, VH160454PQ, VH1604606U, VH160462WV, VH160485GP, VH16055084, VH1606843M, VH1607044U, VH160748G4, VH160832WB, VH16092049 and 96 more |
| Model numbers | H41212RK, H41212RL, H41212RN, H41212RR, H41212YZ, H41212ZA, H41212ZC, H41212ZD |
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 for recall
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1839-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.