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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 64 Multislice CT Scanner System

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  Class 2 Device Recall NeuViz 64 Multislice CT Scanner System see related information
Date Initiated by Firm May 19, 2017
Create Date August 28, 2017
Recall Status1 Terminated 3 on November 19, 2020
Recall Number Z-3044-2017
Recall Event ID 77608
510(K)Number K121972  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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.
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    
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
Action Neusoft 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 Commerce 234
Distribution US Nationwide distribution
Total Product Life Cycle TPLC 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.
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