KaVo Dental Technologies LLC: Medical Device Recall in 2019 - (Recall #: Z-1101-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

cone-beam CT system

Product Classification:

Class II

Date Initiated: December 31, 2018

Date Posted: May 1, 2019

Recall Number: Z-1101-2019

Event ID: 82045

Reason for Recall:

ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

Status: Ongoing

Product Quantity: 230

Code Information:

versions 2.1.0 and 2.1.1

Distribution Pattern:

US distribution in NC

Voluntary or Mandated:

FDA Mandated