FDA Recall Terminated

NeuViz 64 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.

Recall: Z-1279-2019 · Initiated October 22, 2018

Recall

Recall Number
Z-1279-2019
Event Number
82753
Firm
Neusoft Medical Systems Co., Ltd. No. 177-1 Cuangxin Road Hunnan District Shenyang China
FEI Number
3003575350
Product Code
JAK
Status
Terminated
Root Cause
Software design
Initiated
October 22, 2018
Terminated
August 25, 2022

Description

NeuViz 64 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.

Reason

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.

Action

A customer notification letter will be sent to affected customers by email. All the affected systems will be corrected with the upgraded software in the field free of charge.

Distribution

US Nationwide Distribution.

Quantity

37