Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2016 - (Recall #: Z-1650-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 2, 2015

Date Posted: May 18, 2016

Recall Number: Z-1650-2016

Event ID: 73832

Reason for Recall:

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.

Status: Terminated

Product Quantity: 7 units

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

Voluntary or Mandated:

Voluntary: Firm initiated