medical Class II Updated 2019-02-13

NEUSOFT MEDICAL SYSTEMS IMP & EX recalls NeuViz 128 Multi-slice CT Scanner System with software vers

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Affected States: KS, OK, MA
Lot/Code Info: Series number includes: N1281180242E, N1281170231E, N1281180248E
View official government recall

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