Recall Z-1020-2013
DeGotzen · initiated September 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeGotzen XRay unit XGenus Dental X-ray unit.
Codes / lots: 766471
Reason for recall
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-1020-2013
- Initiated
- September 26, 2012
- Posted by FDA
- April 17, 2013
- Terminated
- May 7, 2018
- Product code
- EAP – Unit, X-Ray, Intraoral
- Quantity
- 159 units
- Distribution
- US (nationwide)
- Recalling firm
- DeGotzen, Olgiate Olona Varese