Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Versio
FDA device recall Z-0854-06 · posted 2006-05-09 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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, Switzerlan
- Date initiated
- 2004-10-08
- Date posted
- 2006-05-09
- Date terminated
- 2006-12-31
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANTAGE WINDOWS CT/PET FUSION (K010336) | Ge Medical Systems, Inc. | 2001-02-16 |