| Class 2 Device Recall NeuViz Dual series CT Scanner System |  |
Date Initiated by Firm | March 04, 2013 |
Date Posted | April 23, 2013 |
Recall Status1 |
Terminated 3 on November 22, 2013 |
Recall Number | Z-1166-2013 |
Recall Event ID |
64783 |
510(K)Number | K071308 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system.
NeuViz Dual Multi-slice CT Scanner System 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 |
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 China
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For Additional Information Contact | Mr. Chris McHan 425-4877665 |
Manufacturer Reason for Recall | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. |
FDA Determined Cause 2 | Use error |
Action | The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use.
Customers with questions should contact the Service Support Department by email to nms-service@neusoft.com |
Quantity in Commerce | 25 units |
Distribution | Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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