FDA Recall
Terminated
DeGotzen XRay unit XGenus Dental X-ray unit.
Recall: Z-1020-2013
·
Initiated September 26, 2012
Recall
- Recall Number
- Z-1020-2013
- Event Number
- 64734
- Firm
- DeGotzen via Roma 45 Olgiate Olona Varese Italy
- FEI Number
- 3002994636
- Product Code
- EAP
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- September 26, 2012
- Posted
- April 17, 2013
- Terminated
- May 7, 2018
Description
DeGotzen XRay unit XGenus Dental X-ray unit.
Reason
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
Action
DeGotzen will add new labeling or change existing labeling to correct for the 5 mentioned deficiencies. This correction of the noncompliant products must be made at no cost to the customers. For further questions please call 800-289-6367 ext. 390.
Distribution
US (nationwide)
Quantity
159 units