Recall Z-0854-06 ยท LLZ System, Image Processing, Radiological
General Electric Med Systems LLC
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
| Date | May 9, 2006 (initiated Oct 8, 2004) |
| Status | Terminated |
| Reason | Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A problem associated with this version of software may introduce a shift of up to 1.5 PET Voxels, which can be as much as 8 mm with certain zoom factors. |
| Root cause | Other |
| Action | An Urgent Safety Notice letter, dated October 8, 2004,(5121309-147, rev.E) was distributed to affected customers and a validated software patch that corrected the problem was installed on affected systems via Field Modification Instruction (FMI) 80114. |
| Quantity | 199 |
| Distribution | Distributed in 32 states: AK, AL, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV; Australia, Belgium, Brazil, Canada, Switzerland, Chile, Nigeria, China, France, Egypt, Ireland, Israel, Japan, Korea, the Netherlands, Norway, Ne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010336 | ADVANTAGE WINDOWS CT/PET FUSION Ge Medical Systems, Inc., Feb 16, 2001 |