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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 128 CT Scanner System

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 Class 2 Device Recall NeuViz 128 CT Scanner Systemsee related information
Date Initiated by FirmMay 19, 2017
Create DateAugust 28, 2017
Recall Status1 Terminated 3 on November 19, 2020
Recall NumberZ-3045-2017
Recall Event ID 77608
510(K)NumberK151383 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductNeusoft 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.
Code Information NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version 
FEI Number 3003575350
Recalling Firm/
Manufacturer		 Neusoft Medical Systems Co., Ltd.
NO. 16 Shiji Road
Hunnan Industrial Area
Shenyang China
For Additional Information Contact
281-453-1205
Manufacturer Reason
for Recall		Software defect
FDA Determined
Cause 2		Software design
ActionNeusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release.
Quantity in Commerce154
DistributionUS Nationwide distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JAK
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