Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
FDA Recall Z-0854-06 · Posted 2006-05-09
Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-10-08
Date Terminated2006-12-31
Product Quantity199
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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, New Zealand, Phillipines, Sweden, and Taiwan.
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.