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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 128

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 Class 2 Device Recall NeuViz 128see related information
Date Initiated by FirmAugust 31, 2016
Create DateDecember 23, 2016
Recall Status1 Terminated 3 on January 04, 2018
Recall NumberZ-0876-2017
Recall Event ID 75383
510(K)NumberK121792 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductNeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Code Information NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 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		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
ActionNeusoft 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 Commerce23 units
DistributionUS 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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