Device product
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Z-1650-2016
Product summary
- 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
defect in NeuViz 64 system software