Device product
cone-beam CT system
Z-1101-2019
Product summary
- Event
- Event 82045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 230
- Official record key
device-enforcement:Z-1101-2019
Official wording
Reason: ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Code information: versions 2.1.0 and 2.1.1
Distribution pattern: US distribution in NC
Derived failure modes
-
Device software or design
defect in the device firmware