Z-1020-2013 Class II Terminated
FDA device recall Z-1020-2013 was initiated by DeGotzen on September 26, 2012 and is designated Class II. Reason for recall: It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification The recall status is terminated (terminated May 7, 2018). Affected quantity: 159 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- September 26, 2012
- Termination Date
- May 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 units
Product Description
DeGotzen XRay unit XGenus Dental X-ray unit.
Reason for Recall
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
Distribution Pattern
US (nationwide)
Code Information
766471