GE Healthcare Recalls Vscan Extend Ultrasound Devices Due to EF Calculation Bias
GE Healthcare is recalling 119 Vscan Extend ultrasound devices because the LVivo EF app may overestimate ejection fraction values, potentially affecting clinical assessments.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide