FDA-Device2019-05-01Class II
cone-beam CT system
KaVo Dental Technologies LLC
Hazard
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Sold states
US distribution in NC
Affected count
230
Manufactured in
11727 Fruehauf Dr, N/A, Charlotte, NC, United States
Products
cone-beam CT system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2019Don't want to check this manually?
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