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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 16 MultiSlice CT Scanner System

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  Class 2 Device Recall NeuViz 16 MultiSlice 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-1165-2013
Recall Event ID 64783
510(K)Number K090173  K092742  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system.

The NeuViz 16 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 with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
Code Information Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002.
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 23 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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