Device product
SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
Z-2404-2019
Product summary
- Event
- Event 83556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-2404-2019
Official wording
Reason: The injector holder could potentially fall off together with the injector and the storage box.
Code information: Serial Number 119145 119148 119119 119123 119133 119084 119087 119083 119143 119153 119122 119120
Distribution pattern: US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD
Derived failure modes
-
Unknown
The injector holder could potentially fall off together with the injector and the storage box.