Z-1281-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- October 22, 2018
- Termination Date
- August 25, 2022
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 2
Product Description
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Reason for Recall
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Distribution Pattern
US Nationwide Distribution.
Code Information
Series numbers N16E180037E; N16E180047E