Recall Z-3282-2011 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.
| Date | Sep 27, 2011 (initiated Aug 18, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety. |
| Root cause | Software design |
| Action | GE Healthcare sent "Urgent Medical Device Correction" letters dated August 18, 2011 to all affected customers. The letter included name of product affected and described problem. Recommended actions where provided to customers and they were notified a GE Healthcare representative will contact them for a software system upgrade. For question of this recall contact the GE Service Representative at (800) 437-1171. |
| Quantity | 697 |
| Distribution | Worldwide Distribution: Nationwide distribution including the states of AZ, CA, CT, DC, FL, ID, IL, KY, LA, MD, MI, MN, NJ, NY, OR, PA, PR, TN, TX, VA, WA, and WI; and the countries of VIETNAM, MEXICO, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, ST HELENA, SPAIN, SLOVEN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960265 | ADVANTAGE WINDOWS WITH FUNCTOOL OPTION GE Medical Systems, Jul 3, 1996 |