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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 Recall
NeuViz 16 MultiSlice CT Scanner System
see related information
Date Posted July 26, 2012
Recall Status1 Terminated on September 17, 2012
Recall Number Z-2083-2012
Recall Event ID 62481
Premarket Notification
510(K) Numbers
K090173  K092742 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
Code Information Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.
Recalling Firm/
Manufacturer
Philips And Neusoft Medical Systems Co., Ltd.
16 Century Road, Neusoft Park,
Hun Nan Industrial Area
Shenyang, Liaoning
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips Healthcare North America Company sent an "Urgent Device Correction NeuViz 16 X-Ray Tube Oil-accumulator Detached" letter and attachments of Annex A Method to Identify Affected Products and Annex B Instruction for Mechanic, dated June 14, 2012, to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to follow the instructions on Annex A and Annex B. Philips and Neusoft Medical Systems planned to release the mandatory Field Change Order (FCO) and FCO kits to all customers by the end of June 2012. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems, Co., LTD by e-mail to NMS-SERVICE@NEUSOFT.COM.
Quantity in Commerce 15 units distributed in the US
Distribution Nationwide Distribution -- North Carolina, Ohio, and Texas.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = NEUSOFT MEDICAL SYSTEMS CO., LTD.
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