Company:Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 9/6/2017
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 126.96.36.19958 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 188.8.131.5221+P11 or previous version 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-3044-2017
Neusoft Medical Systems Co., Ltd. Shenyang, China on 5/19/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE