Class 2 Device Recall NeuViz Dual series computed Tomography Scanner System

• Date Initiated by Firm: June 23, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on September 24, 2010
• Recall Number: Z-2307-2008
• Recall Event ID: 48727
• 510(K)Number: K062451 K071308
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: NeuViz Dual series computed Tomography Scanner System, X-Ray System
• Code Information: Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
• FEI Number: 3003575350
• Recalling Firm/ Manufacturer: Philips And Neusoft Medical Systems Co., Ltd.; 16 Century Road, Neusoft Park,; Hun Nan Industrial Area; Shenyang, Liaoning China
• Manufacturer Reason for Recall: Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 6/23/08/08, the Philips Neusoft sent a letter dated 6/10/08 to their US customers explaining the problem, under what circumstances it can occur, and the actions that should be taken by the customer/user in order to prevent risks for patients or users. The field correction is install a R-host bracket to aid supporting of the R-host computer. The letter included additional information to customers who had already received the field action (this was an on-going activity that was re-classified as a potential safety). Customers did not receive the additional information about the status of their upgrade if the upgrade had not occurred at the time of the mailing. They were informed that they would be contacted by Newsoft Medical systems representative for the planning of this repair. If you have questions contact Service Support Department at nms-service@neusoft.com.
• Quantity in Commerce: 15 units in US
• Distribution: The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, 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 = JAK