Recall Z-1020-2013— DeGotzen
Class II · Terminated
Class II FDA medical device recall by DeGotzen, initiated 2012-09-26, terminated 2018-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- DeGotzen
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-26
- Terminated
- 2018-05-07
- Firm location
- Olgiate Olona Varese, N/A, Italy
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.