Device product
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Z-2176-2014
Product summary
- Event
- Event 68798
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1
- Official record key
device-enforcement:Z-2176-2014
Official wording
Reason: Unit was mislabeled with a factory label showing 32 KW output power.
Code information: Serial Number A5410000042
Distribution pattern: US in the state of WV
Derived failure modes
-
Labeling or packaging
mislabeled