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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 Systemsee related information
Date Initiated by FirmSeptember 23, 2004
Date PostedNovember 16, 2004
Recall Status1 Terminated 3 on January 25, 2005
Recall NumberZ-0196-05
Recall Event ID 30170
510(K)NumberK913120 
Product Classification System, X-Ray, Angiographic - Product Code IZI
ProductPOLYSTAR 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/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactRoland Richter
610-448-1777
Manufacturer Reason
for Recall
Orbital gears may exhibit excess wear
FDA Determined
Cause 2
Other
ActionThe 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 Commerce82 units
DistributionThe product was shipped to medical facilities nationwide and government accounts in KS and MI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
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