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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz

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 Class 2 Recall
NeuViz
see related information
Date Posted September 17, 2008
Recall Status1 Open
Recall Number Z-2235-2008
Recall Event ID 48657
Premarket Notification
510(K) Numbers
K062451  K071308 
Product Classification System, X-Ray, Tomography, Computed - 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
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
DESIGN: 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 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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