Skip to content
Recall Observatory FDA recall evidence

Device product

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

Z-1650-2016

May 02, 2015

Class II

Product summary

Firm
Neusoft Medical Systems Co., Ltd.
Event
Event 73832
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-1650-2016

Official wording

Reason: 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.

Code information: Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E

Distribution pattern: US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    defect in NeuViz 64 system software