cone-beam CT system
- Company
- Kavo Dental Technologies Llc
- Recall Initiated
- December 31, 2018
- Recall Number
- Z-1101-2019
- Quantity
- 230
- Firm Location
- Charlotte, NC
Reason for Recall
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Distribution
US distribution in NC
Lot / Code Info
versions 2.1.0 and 2.1.1
Root Cause
Device Design
Action Taken
Palodex Group Oy sent a Notification letter to affected customers on or about December 31, 2018. The letter identified the affected product, problem and actions to be taken. The firm corrective action is to update the firmware of ORTHOPANTOMOGRAPH OP 3D of the defective units. Acknowledgement to the field correction letter is requested within 30 days from receiving the letter.