Class 3 Device Recall POLYSTAR XRay System

• Date Initiated by Firm: September 23, 2004
• Date Posted: November 16, 2004
• Recall Status: Terminated on January 25, 2005
• Recall Number: Z-0195-05
• Recall Event ID: 30170
• 510(K)Number: K913120
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: POLYSTAR, Angiographic X-Ray System, Model 1148902
• Code Information: Serial Numbers 01000 through 01267 and 02001through 02117
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: Orbital gears may exhibit excess wear
• FDA Determined Cause: Other
• Action: The recalling firm issued Update Instructions, AX077/04/S, to Siemen''s Customer Service Representative (CSR) to visit affected sites and check the orbital gears for excessive wear. If the CSR finds gears exhibiting excessive wear the orbital gears will be replaced. If no wear is observed the gears will be lubricated as a preventive measure.
• Quantity in Commerce: 43 units
• Distribution: The product was shipped to medical facilities nationwide and government accounts in KS and MI.
• 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 = IZI