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U.S. Department of Health and Human Services

Class 2 Device Recall NEUVIZ DUAL MULTISLICE CT SCANNER SYSTEM

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  Class 2 Device Recall NEUVIZ DUAL MULTISLICE CT SCANNER SYSTEM see related information
Date Initiated by Firm April 10, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on October 29, 2010
Recall Number Z-0001-2009
Recall Event ID 50138
510(K)Number K062451  K071308  
Product Classification System, x-ray, tomography, computed - Product Code JAA
Product NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software).

Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Code Information Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and NDHR080003.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
425-487-7602
Manufacturer Reason
for Recall		 An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.
FDA Determined
Cause 2		 Software design
Action A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.
Quantity in Commerce 19 units in the US.
Distribution Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, 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 = JAA and Original Applicant = NEUSOFT MEDICAL SYSTEMS CO., LTD.
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