Recall – Software doesn’t handle abnormal case

Company: NEUSOFT MEDICAL SYSTEMS IMP & EX
Date of Enforcement Report: 2/5/2019
Class II

PRODUCT

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.

Recall Number: Z-0773-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

NEUSOFT MEDICAL SYSTEMS IMP & EX, Shenyang, China on 1/9/2019. FDA Mandated

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION
U.S. distributed in KS, OK, and MA

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