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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz Dual Series Computed Tomography Scanner System

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 Class 2 Recall
NeuViz Dual Series Computed Tomography Scanner System
see related information
Date Posted January 04, 2011
Recall Status1 Terminated on April 15, 2011
Recall Number Z-0846-2011
Recall Event ID 54638
Premarket Notification
510(K) Numbers
K062451  K071308 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
Code Information Part number: NeuViz Dual 989605651321. SERIAL NUMBERS: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012.
Recalling Firm/
Manufacturer
Philips And Neusoft Medical Systems Co., Ltd.
Neusoft Park,
Hun Nan Industrial Area
Shenyang, Liaoning
Manufacturer Reason
for Recall
Potential for the CT patient table top to become detached from the carrier due to missing washers.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees. The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury. Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at nms-service@neusoft.com or Service Support Department at helpdesk@neusoft.com for questions about this recall.
Quantity in Commerce 26 devices
Distribution Nationwide Distribution including NC
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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