| Class 2 Device Recall NeuViz 64 Multislice CT Scanner System |  |
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 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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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 |
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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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