GE Voluson E8 Recall

[David M. Smith]

Recall of GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1, 6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01



REASON
Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential
inaccuracies of fetal cardiac measurements that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE, 1,637 units