Recall Z-2312-2008 ยท LLZ System, Image Processing, Radiological
GE Healthcare
Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.
| Date | Sep 20, 2008 (initiated May 1, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety. |
| Root cause | Software design |
| Action | Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative. |
| Quantity | 5,249 (2,104 US/ 3,145 OUS) |
| Distribution | AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041521 | VOLUME VIEWER PLUS General Electric Medical Systems, Jun 22, 2004 |