Recall Z-0901-2013— GE Healthcare, LLC

Name: FDA recall Z-0901-2013
Creator: U.S. Food and Drug Administration
Published: 2012-05-25

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-05-25, terminated 2014-01-28. It names 2 FDA 510(k) clearances: K041521, K972399. Product: GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.. Reason: Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-25
Terminated: 2014-01-28
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K041521 — VOLUME VIEWER PLUSGeneral Electric Medical Systems·cleared 2004-06-22
K972399 — ADVANTAGE WINDOWS VOLUME RENDERING OPTIONGe Medical Systems, Inc.·cleared 1997-09-23

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 Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.

Reason for recall

Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

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