Z-0196-05

POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505

Name: Z-0196-05 POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-09-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-09-23 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505 on 2004-09-23. The reason FDA records is "Orbital gears may exhibit excess wear". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0196-05
Status: Terminated
Initiated: 2004-09-23
Posted: 2004-11-16
Terminated: 2005-01-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Orbital gears may exhibit excess wear
FDA root 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: 82 units
Distribution: The product was shipped to medical facilities nationwide and government accounts in KS and MI.
Product codes and lots: 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

Product code IZI

K913120Class IIPolystar Angiographic X-Ray SystemSiemens Medical Solutions USA, Inc. / cleared 1991-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)