Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2017 - (Recall #: Z-3044-2017)

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:

Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Product Classification:

Class II

Date Initiated: May 19, 2017

Date Posted: September 6, 2017

Recall Number: Z-3044-2017

Event ID: 77608

Reason for Recall:

Software defect

Status: Terminated

Product Quantity: 234

Code Information:

NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version

Distribution Pattern:

US Nationwide distribution

Voluntary or Mandated:

FDA Mandated