FDA recall Z-1101-2019
KaVo Dental Technologies LLC · Class II · device
Product
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
US distribution in NC
Key facts
- Status
- Ongoing
- Initiation date
- 2018-12-31
- Report date
- 2019-05-01
- Voluntary/Mandated
- FDA Mandated
- Location
- Charlotte, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2019