cone-beam CT system
FDA Recall #Z-1101-2019 — Class II — December 31, 2018
Product Description
cone-beam CT system
Reason for Recall
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Recalling Firm
KaVo Dental Technologies LLC — Charlotte, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
230
Distribution
US distribution in NC
Code Information
versions 2.1.0 and 2.1.1
Status
Ongoing
Voluntary / Mandated
FDA Mandated