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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 64

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  Class 2 Device Recall NeuViz 64 see related information
Date Initiated by Firm August 31, 2016
Create Date December 23, 2016
Recall Status1 Terminated 3 on January 04, 2018
Recall Number Z-0875-2017
Recall Event ID 75383
510(K)Number K121792  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product NeuViz 64 Multi-slice CT Scanner Systems

Code Information NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version.  NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 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		 The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
FDA Determined
Cause 2		 Software design
Action Neusoft Medical Systems Co. Ltd. planned action to bring into compliance. 1.Affected Customers will be notified by letter to provide them a description of the affected device, instructions for using the device prior to correction, hazards associated with the defect, and a statement of corrective actions to be taken at no cost to the owner. 2.Field Service Engineers will visit owner sites to install a software update which resolves the defect. 3.Corrections will be made at no cost to the owner 4.Corrections will be completed by May 11, 2017. CDRH approves the CAP subject to the following conditions: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call (281) 453-1205.
Quantity in Commerce 23 units
Distribution US 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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = NEUSOFT MEDICAL SYSTEMS CO., LTD.
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