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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 May 23, 2011
Recall Status1 Terminated on August 24, 2011
Recall Number Z-2241-2011
Recall Event ID 58582
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 Numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, and N16E100023.
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 Neusoft Medical Systems
425-487-7665
Manufacturer Reason
for Recall
Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Neusoft Medical Systems sent an Urgent Device Correction Notification letter dated February 9, 2011, via certified mail to their distributor NEUISYS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of combined images. Instead, use MPR Batch for diagnostic reviews until the planned upgrade is provided to the product. Neusoft Medical System and Philips Medical System released the mandatory Field Change Order (FCO) by March 31, 2011. All nine affected systems will be updated with aforementioned kits in six months after the release. Consignees were instructed to contact Service Support Department by e-mail to nms-service@neusoft.com.
Quantity in Commerce 9 units distributed in US
Distribution Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX.
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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