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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 Scanne
Recalled February 13, 2019 · FDA recall Z-0773-2019 · NEUSOFT MEDICAL SYSTEMS IMP & EX
Hazard
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. · FDA Class II
Units
3
Sold at
US Distribution in states of: KS, OK and MA.
Description
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.
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.
Manufacturer(s)
NEUSOFT MEDICAL SYSTEMS IMP & EX
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →