Neusoft Medical System Co: Medical Device Recall in 2015 - (Recall #: Z-1693-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Neusoft NeuViz 64 Multi-slice CT Scanner System

Product Classification:

Class II

Date Initiated: March 8, 2014

Date Posted: June 24, 2015

Recall Number: Z-1693-2015

Event ID: 71306

Reason for Recall:

The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. Failure is indicated by pin or ring artifact in the image

Status: Terminated

Product Quantity: 5 installed in US

Code Information:

NeuViz 16/64 Series

Distribution Pattern:

Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.

Voluntary or Mandated:

Voluntary: Firm initiated