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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series CT Scanner System

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 Class 2 Recall
NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series CT Scanner System
see related information
Date Posted December 04, 2012
Recall Status1 Terminated on July 08, 2013
Recall Number Z-0466-2013
Recall Event ID 63553
Premarket Notification
510(K) Numbers
K062451  K071308  K090173  K092742 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Code Information NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
Recalling Firm/
Manufacturer
Philips And Neusoft Medical Systems Co., Ltd.
16 Century Road, Neusoft Park,
Hun Nan Industrial Area
Shenyang, Liaoning
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at nms-service@neusoft.com For questions regarding this recall call 425-487-7665.
Quantity in Commerce 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Distribution Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
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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