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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz Dual series Computed Tomography (CT) Scanner System

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 Class 2 Recall
NeuViz Dual series Computed Tomography (CT) Scanner System
see related information
Date Posted August 19, 2010
Recall Status1 Terminated on August 23, 2010
Recall Number Z-2237-2010
Recall Event ID 49012
Premarket Notification
510(K) Numbers
K062451  K071308 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Code Information Serial Number: 400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003.
Recalling Firm/
Manufacturer
Neuisys, LLC
1500 Pinecroft Rd Ste 212
Greensboro, North Carolina 27407-3808
For Additional Information Contact Kevin Zhang
877-299-9052
Manufacturer Reason
for Recall
The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.
FDA Determined
Cause 2
DESIGN: Software Design
Action On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China. The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of "Incorrect Reference Line in the Film". When a "Head first, Couch out" or a "Feet first, Couch in" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in "FILM" display mode. The acquired images accurately represent the exact positions planned on the original view. The incorrect/unmatched reference line in film may result in incorrect diagnosis. The consignees are advised not to stop or pause during Surview acquisition while PNMS in China will provide the updated software patch to all affected systems free of charge. The Field Change Order #FCOP-08-CT-NMS-008 SP4 will be implemented by NEUISYS Imaging Systems Solutions in Greensboro, NC., who is a distributor for PNMS. Consignees are advised to e-mail Service Support Department of PNMS at helpdesk@pnms.neusoft.com regarding the recall.
Quantity in Commerce 19 units in the US
Distribution Nationwide Distribution
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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