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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 128 Multislice CT Scanner System

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  Class 2 Device Recall NeuViz 128 Multislice CT Scanner System see related information
Date Initiated by Firm January 09, 2019
Create Date February 05, 2019
Recall Status1 Terminated 3 on August 25, 2022
Recall Number Z-0773-2019
Recall Event ID 81920
510(K)Number K151383  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product NeuViz 128 Multi-slice CT Scanner System with
software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1
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 Series number includes: N1281180242E, N1281170231E, N1281180248E
Recalling Firm/
Manufacturer		 NEUSOFT MEDICAL SYSTEMS IMP & EX
16 Shiji Road
Dongling
Shenyang China
Manufacturer Reason
for Recall		 For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
FDA Determined
Cause 2		 Software design
Action The firm, Neurosoft Medical Systems Co., Inc., issued a notice to its customers dated 11/26/2018. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: Please plan surview length accurately according the clinical requirement, and not interrupt(abort or skip) scanning during the surview scan if the planning length is over 500mm. The defect will be remedied by updating software. Field Change Order related to software updated will be released to the affected systems in Jan, 2019. The affected systems will be upgraded with updated software in the field free of charge in 6 months after the FCO release. If you have any questions, contact Senior TQM Director at Tel: +86 024-2335831 1 or email: wangzq@neusoft.com.
Quantity in Commerce 3
Distribution US Distribution in states of: KS, OK and MA.
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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