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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz

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  Class 2 Device Recall NeuViz see related information
Date Initiated by Firm December 17, 2007
Date Posted September 17, 2008
Recall Status1 Terminated 3 on February 16, 2012
Recall Number Z-2235-2008
Recall Event ID 48657
510(K)Number K062451  K071308  
Product Classification Computed Tomography Scanner - Product Code JAK
Product NeuViz Dual series computed Tomography Scanner System, X-Ray System
The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Code Information Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
Recalling Firm/
Manufacturer		 Philips And Neusoft Medical Systems Co., Ltd.
Neusoft Park,
Hun Nan Industrial Area
Shenyang, Liaoning China
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Labeling of patient position on scanned image does not match actual patient orientation.
FDA Determined
Cause 2		 Software design
Action On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.
Quantity in Commerce 15 units
Distribution Distribution in US: CO, FL, KY, NC, SC, TN, and TX.
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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