Device product
DeGotzen XRay unit XGenus Dental X-ray unit.
Z-1020-2013
Product summary
- Firm
- DeGotzen
- Event
- Event 64734
- Status
- Terminated
- Classification
- Class II
- Quantity
- 159 units
- Official record key
device-enforcement:Z-1020-2013
Official wording
Reason: It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
Code information: 766471
Distribution pattern: US (nationwide)
Derived failure modes
-
Unknown
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification