FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.
- Recall number
- Z-0196-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.
- Status
- Terminated
- Initiated
- 2004-09-23
- Posted
- 2004-11-16
- Terminated
- 2005-01-25
- Reason
- Orbital gears may exhibit excess wear
- 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
- 82 units
- Distribution
- The product was shipped to medical facilities nationwide and government accounts in KS and MI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K913120"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28