Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2017 - (Recall #: Z-0875-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

NeuViz 64 Multi-slice CT Scanner Systems

Product Classification:

Class II

Date Initiated: August 31, 2016

Date Posted: January 4, 2017

Recall Number: Z-0875-2017

Event ID: 75383

Reason for Recall:

The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.

Status: Terminated

Product Quantity: 23 units

Code Information:

NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version

Distribution Pattern:

US Distribution

Voluntary or Mandated:

FDA Mandated