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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 October 22, 2018
Create Date May 21, 2019
Recall Status1 Terminated 3 on August 25, 2022
Recall Number Z-1280-2019
Recall Event ID 82753
510(K)Number K151383  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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 Series numbers  N1281160084E; N1281160085E; N1281170161 E; N1281170231E; N1281180242E; N1281180248E
Recalling Firm/
Manufacturer		 Neusoft Medical Systems Co., Ltd.
No. 177-1 Cuangxin Road
Hunnan District
Shenyang China
For Additional Information Contact
024-23358311
Manufacturer Reason
for Recall		 Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
FDA Determined
Cause 2		 Software design
Action A customer notification letter will be sent to affected customers by email. All the affected systems will be corrected with the upgraded software in the field free of charge.
Quantity in Commerce 6
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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = NEUSOFT MEDICAL SYSTEMS CO., LTD.
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