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U.S. Department of Health and Human Services

Class 3 Device Recall POLYSTAR T.O.P. XRay System

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  Class 3 Device Recall POLYSTAR T.O.P. XRay System see related information
Date Initiated by Firm September 23, 2004
Date Posted November 16, 2004
Recall Status1 Terminated 3 on January 25, 2005
Recall Number Z-0196-05
Recall Event ID 30170
510(K)Number K913120  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product POLYSTAR T.O.P., Angiographic X-Ray System, Model
Numbers 1148902 and 4784505.
Code Information Serial Numbers for model 1148902: 01000 through 01267, 02001 through 02117. Serial numbers for model4784505: 03001 through 035158, 04001 through 04136, and 05001 through 05098
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
Orbital gears may exhibit excess wear
FDA Determined
Cause 2
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 82 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.