Device product
SOMATOM Force; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.
Z-0971-2015
Product summary
- Event
- Event 69957
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-0971-2015
Official wording
Reason: Artifacts are found in acquired imaging on the SOMATOM Force.
Code information: Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.
Distribution pattern: PA, MA, MN, SC, MD, and TX.
Derived failure modes
-
Unknown
Artifacts are found in acquired imaging on the SOMATOM Force.