Neusoft Medical Systems Co., Ltd.: Medical Device Recall in 2019 - (Recall #: Z-1280-2019)

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 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: October 22, 2018

Date Posted: May 29, 2019

Recall Number: Z-1280-2019

Event ID: 82753

Reason for Recall:

Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.

Status: Terminated

Product Quantity: 6

Code Information:

Series numbers N1281160084E; N1281160085E; N1281170161 E; N1281170231E; N1281180242E; N1281180248E

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

FDA Mandated