Recall Z-0386-06 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
General Electric Med Systems LLC
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
| Date | Jan 11, 2006 (initiated Sep 2, 2004) |
| Status | Terminated |
| Reason | The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient. |
| Root cause | Other |
| Action | Devices will have software upgrades done by GE Field Service Technicians. The upgrade will include a dialog box which will display on the screen when prior data exists and a new patient is being registered. |
| Quantity | 393 |
| Distribution | nationwide and worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014097 | GE LOGIQ 5 GE Medical Systems, Jan 10, 2002 |