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Neusoft Medical Systems Co., Ltd. recalls NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Recalled May 18, 2016 · FDA recall Z-1650-2016 · Neusoft Medical Systems
Hazard
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options. · FDA Class II
Units
7 units
Sold at
US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
Description
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
Product
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Manufacturer(s)
Neusoft Medical Systems Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →