NEUSOFT MEDICAL SYSTEMS IMP & EX: Medical Device Recall in 2019 - (Recall #: Z-0773-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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: January 9, 2019

Date Posted: February 13, 2019

Recall Number: Z-0773-2019

Event ID: 81920

Reason for Recall:

For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.

Status: Terminated

Product Quantity: 3

Code Information:

Series number includes: N1281180242E, N1281170231E, N1281180248E

Distribution Pattern:

US Distribution in states of: KS, OK and MA.

Voluntary or Mandated:

FDA Mandated