Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 26, 2019
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 ultra
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare, LLC recalled LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Exte… - a moderate-severity action.
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Exte… was recalled by Ge Healthcare, LLC in June 26, 2019. Reason: Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the…. Check the official notice for the remedy. Verify recall #Z-1839-2019 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the….
- Moderate
- severity level
- 119 units
- affected scope
- Class II
- classification
- June 26, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1839-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1839-2019) was formally reported on June 26, 2019, with the manufacturer initiating the action on May 21, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 119 units.
The documented reason for this recall is: Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product. Distribution data in the federal record shows the product reached: 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, Irel…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
119 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1839-2019 |
| Date reported | June 26, 2019 |
| Date initiated | May 21, 2019 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 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, K… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1839-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ge Healthcare, LLC. Units affected: 119 units.
Why was this product recalled? ▼
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1839-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1839-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 26, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.