Recall Z-0901-2013 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
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
| Date | Mar 1, 2013 (initiated May 25, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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, p |
| Quantity | 363 |
| Distribution | 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, GERMA |
| FDA record | Open on fda.gov |