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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz Dual series CT Scanner System

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  Class 2 Device Recall NeuViz Dual series CT Scanner System see related information
Date Initiated by Firm March 04, 2013
Date Posted April 23, 2013
Recall Status1 Terminated 3 on November 22, 2013
Recall Number Z-1166-2013
Recall Event ID 64783
510(K)Number K071308  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system.

NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Code Information Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
Recalling Firm/
Manufacturer		 Philips And Neusoft Medical Systems Co., Ltd.
16 Century Road, Neusoft Park,
Hun Nan Industrial Area
Shenyang, Liaoning China
For Additional Information Contact Mr. Chris McHan
425-4877665
Manufacturer Reason
for Recall		 User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
FDA Determined
Cause 2		 Use error
Action The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use. Customers with questions should contact the Service Support Department by email to nms-service@neusoft.com
Quantity in Commerce 25 units
Distribution Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
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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