Device product
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Z-1642-2014
Product summary
- Event
- Event 67958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-1642-2014
Official wording
Reason: The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Code information: SN: MXA1170108, MXA1270262
Distribution pattern: Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
Derived failure modes
-
Unknown
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.