Neusoft Medical Systems Co., Ltd. recalls Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.…

Recall date

May 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3044-2017

FDA classification

Class II

Brand / firm

Neusoft Medical Systems Co., Ltd.

Sold / distributed

US Nationwide distribution

Why it was recalled

Software defect

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.