Recall Z-1960-2012— GE Healthcare, LLC

Name: FDA recall Z-1960-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-24

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-05-24, terminated 2012-12-06. It names 2 FDA 510(k) clearances: K012313, K010336. Product: GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).. Reason: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Terminated: 2012-12-06
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K012313 — CT COLONOGRAPHY/NAVIGATOR2Ge Medical Systems, Inc.·cleared 2001-08-07
K010336 — ADVANTAGE WINDOWS CT/PET FUSIONGe Medical Systems, Inc.·cleared 2001-02-16

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 Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET).

Reason for recall

GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th

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