Recall Z-1101-2019 ยท OAS X-Ray, Tomography, Computed, Dental
KaVo Dental Technologies LLC
cone-beam CT system
| Date | Dec 31, 2018 |
| Status | Open, Classified |
| Reason | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 230 |
| Distribution | US distribution in NC |
| FDA record | Open on fda.gov |