FDA Device

DeGotzen XRay unit XGenus Dental X-ray unit.

Hazard

It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification

What You Should Do

Remedy

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.

Products

DeGotzen XRay unit XGenus Dental X-ray unit.
Brand
DeGotzen via Roma 45 Olgiate Olona Varese Italy
UPC
766471

Units Affected

159 units