FDA-Device2013-04-24Class II

DeGotzen XRay unit XGenus Dental X-ray unit.

DeGotzen
Hazard

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

Sold states
US (nationwide)
Affected count
159 units
Manufactured in
via Roma 45, N/A, Olgiate Olona Varese, N/A, Italy
Products
DeGotzen XRay unit XGenus Dental X-ray unit.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1020-2013

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