Device product
The GC80 Digital X-ray Imaging System
Z-0726-2018
Product summary
- Event
- Event 78679
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-0726-2018
Official wording
Reason: An image was obtained with over exposure during a Thorax examination using the AEC function.
Code information: Accession Number 1310459
Distribution pattern: Nationwide US
Derived failure modes
-
Unknown
An image was obtained with over exposure during a Thorax examination using the AEC function.