Recall Z-1839-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
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, Mode
| Date | May 21, 2019 |
| Status | Open, Classified |
| Reason | Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product. |
| Root cause | Software design |
| Action | GE Healthcare notified customers on about 05/21/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to discontinue use of the LVivo EF app until a correction is available and installed on the Vscan Extend. However Vscan Extend can continue to be used for all other existing cleared indications including all other Vscan Extend apps and measurements. GE Healthcare will correct all affected products at no cost. When the LVivo EF app update is available through GE Marketplace, customers will receive an email notification sent to the email address they set up during t |
| Quantity | 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, Korea (Republic Of), Netherlands, Romania, Sweden, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161588 | Vscan Extend GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Aug 31, 2016 |