Company: GE Healthcare, LLC
Date of Enforcement Report: 9/25/2013
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. Recall Number Z-2241-2013
GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
GE Healthcare, LLC, Waukesha, WI on3/272012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
318 (28 USm 290 OUS)
Nationwide and Internationally