Company: Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report: 5/29/2019
Class II
PRODUCT
NeuViz 64 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.
Recall Number: Z-1279-2019
NeuViz 128 Multi-slice CT Scanner System
Recall Number: Z-1280-2019
NeuViz 16 Essence Multi-slice CT Scanner System
Recall Number: Z-1281-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Neusoft Medical Systems Co., Ltd. on 10/22/2019. FDA Mandated.
VOLUME OF PRODUCT IN COMMERCE
37
DISTRIBUTION
US Nationwide