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U.S. Department of Health and Human Services

Class 2 Device Recall CT Scanner

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  Class 2 Device Recall CT Scanner see related information
Date Initiated by Firm May 02, 2015
Create Date May 11, 2016
Recall Status1 Terminated 3 on November 04, 2016
Recall Number Z-1650-2016
Recall Event ID 73832
510(K)Number K121792  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Code Information Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E
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		 It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
FDA Determined
Cause 2		 Device Design
Action An upgraded software version (1.0.5.2619+P11) was released on May 7, 2015. The FCO was released to the service engineers of Neusoft Medical Systems USA, which is subsidiary of the reporting firm, and the engineers performed FCO for each affected device together with the distributors' engineers. The corrections (FCOs to upgrade software) on all the affected systems in the USA have been completed. At present (4/27/16) there is no longer this issue on the systems, so no further actions are needed for customers/distributors. However, the recalling firm shall inform the direct accounts of this fix before May 5, 2016. The recalling firm will submit the communication evidence ASAP once they have evidence of the communication. For further questions, please call (281) 453-1205.
Quantity in Commerce 7 units
Distribution US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
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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