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.
FDA Recall Z-0901-2013 · Posted 2013-03-01
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-05-25
Date Terminated2014-01-28
Product Quantity363
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.
Firm Action
GE Healthcare sent a "Urgent Medical Device Correction " letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to discontinue use of the Edit Contour feature until this software functionality is corrected or replaced.
GE Healthcare will correct all affected systems by providing a software upgrade at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers:
United States: 800 437 1171
Japan: 0120 - 055 - 919
For other countries, please contact your local GE Healthcare Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.