Device product
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Z-0019-2016
Product summary
- Event
- Event 72091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 113 total
- Official record key
device-enforcement:Z-0019-2016
Official wording
Reason: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
Code information: Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Device software or design
software bug