Z-0773-2019 Class II Terminated
FDA device recall Z-0773-2019 was initiated by NEUSOFT MEDICAL SYSTEMS IMP & EX on January 9, 2019 and is designated Class II. Reason for recall: For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan … The recall status is terminated (terminated August 25, 2022). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- January 9, 2019
- Termination Date
- August 25, 2022
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 3
Product Description
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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
For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
Distribution Pattern
US Distribution in states of: KS, OK and MA.
Code Information
Series number includes: N1281180242E, N1281170231E, N1281180248E