Recall Z-0113-2008 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Ge Healthcare
GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.
| Date | Nov 7, 2007 (initiated Jul 6, 2007) |
| Status | Terminated |
| Reason | When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities. |
| Root cause | Software design |
| Action | GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers. |
| Quantity | 521 Units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM General Electric Co., Jul 12, 2006 |