Recall Z-2241-2013— GE Healthcare, LLC

Name: FDA recall Z-2241-2013
Creator: U.S. Food and Drug Administration
Published: 2012-03-27

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-03-27, terminated 2014-11-21. It names one FDA 510(k) clearance: K110573. Product: GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-03-27
Terminated: 2014-11-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K110573 — READY VIEWGe Healthcare (Ge Medical Systems Scs)·cleared 2011-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.