Device product
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are 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-0608-2017
Product summary
- Event
- Event 75677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 systems
- Official record key
device-enforcement:Z-0608-2017
Official wording
Reason: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
Code information: Model Number: 10430603 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029
Distribution pattern: Nationwide distribution to MI, NY, CA, KY, ND, and NE.
Derived failure modes
-
Device software or design
software update that provides bug