FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Cathcor/LX/Desktop, System, X-Ray, Angiographic
- Recall number
- Z-1032-03
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Cathcor/LX/Desktop, System, X-Ray, Angiographic
- Status
- Terminated
- Initiated
- 2002-11-27
- Posted
- 2003-07-19
- Terminated
- 2006-10-03
- Reason
- Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
- Root cause
- Other
- Action
- A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.
- Quantity
- 9
- Distribution
- 5 Hospitals/Clinics in the US.
- Lot, serial or model codes
- Serial Numbers:01029, 01033, 01034,01062, 01108, 01110, 01121, 01125, 02048.
- 510(k) numbers
- ["K002137"]
- 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