Device product
SOMATOM Emotion 6; 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-1934-2015
Product summary
- Event
- Event 71484
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 total
- Official record key
device-enforcement:Z-1934-2015
Official wording
Reason: A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Code information: model numbers: 10165888 with serial numbers: 29161 29185 29186 29165 29176 29181 29198
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.