FDA Enforcement
Class II
Terminated
DeGotzen XRay unit XGenus Dental X-ray unit.
Recall: Z-1020-2013
·
Reported April 24, 2013
Enforcement
- Recall Number
- Z-1020-2013
- Event ID
- 64734
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DeGotzen
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2013
- Initiation Date
- September 26, 2012
- Classification Date
- April 17, 2013
- Termination Date
- May 7, 2018
- Address
- via Roma 45, N/A, Olgiate Olona Varese, N/A, N/A, Italy
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
Code Info
766471
Distribution
US (nationwide)
Quantity
159 units