NEUSOFT MEDICAL SYSTEMS IMP & EX recalls 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…

Recall date

January 9, 2019

Source

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

Recall number

Z-0773-2019

FDA classification

Class II

Brand / firm

NEUSOFT MEDICAL SYSTEMS IMP & EX

Sold / distributed

US Distribution in states of: KS, OK and MA.

Why it was recalled

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.

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

What was recalled

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.