Z-1101-2019 Class II Ongoing

Recalled by KaVo Dental Technologies LLC — Charlotte, NC

Recall Details

Product Type
Devices
Report Date
May 1, 2019
Initiation Date
December 31, 2018
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
230

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

Distribution Pattern

US distribution in NC

Code Information

versions 2.1.0 and 2.1.1