Z-1101-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- December 31, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 230
Product Description
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 Pattern
US distribution in NC
Code Information
versions 2.1.0 and 2.1.1