Cl II Neusoft Medical NeuViz 64

Company:Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 9/6/2017
ClasslI:

PRODUCT

Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+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

REASON
Software defect.

RECALLING FIRM/MANUFACTURER
Neusoft Medical Systems Co., Ltd. Shenyang, China on 5/19/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
234

DISTRIBUTION
Nationwide

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