GE Healthcare recalls Vscan Extend ultrasound devices with LVivo EF app due to overestimation of ejection fraction values. Affected models include Vscan Extend Dual DICOM, USB, and Wi-Fi versions with specific model numbers.
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
GE Healthcare is recalling Vscan Extend ultrasound devices that use the LVivo EF app because the app overestimates ejection fraction (EF) values. This could lead to inaccurate heart health assessments if used for medical diagnosis. The recall affects specific model numbers and versions of the device.
The LVivo EF app on the Vscan Extend device calculates ejection fraction (EF) values incorrectly, potentially overestimating heart function. This could lead to inaccurate medical assessments if the app is used for heart health evaluations.
Healthcare professionals who use the Vscan Extend ultrasound system with the LVivo EF app are most at risk. The recall applies to specific model numbers and versions sold under the product names listed.
Check if your Vscan Extend device has model numbers H41212ZA, H41212RN, H41211RK, H41212YZ, H41212RL, H41212ZD, H41212RR, or H41212ZC. The device is sold under product names like Vscan Extend Dual DICOM, USB, or Wi-Fi versions.
Identify your Vscan Extend device model number by checking the serial number (UDI) on the device or packaging.
Reach out to GE Healthcare for guidance on whether your device is affected and what steps to take next.
The LVivo EF app on the Vscan Extend device overestimates ejection fraction (EF) values, which could lead to inaccurate heart health assessments.
Affected models include Vscan Extend Dual DICOM (H41212ZA, H41212RN), Dual USB (H41212RK), Dual Wi-Fi (H41212YZ, H41212RL), Sector DICOM (H41212ZD), Sector USB (H41212RR), and Sector Wi-Fi (H41212ZC).
No, the recall does not require immediate discontinuation. Affected users should contact GE Healthcare for specific guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1839-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1839-2019 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
