Z-1032-03

Cathcor/LX/Desktop, System, X-Ray, Angiographic

Name: Z-1032-03 Cathcor/LX/Desktop, System, X-Ray, Angiographic
Creator: Siemens Medical Solutions USA, Inc
Published: 2002-11-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2002-11-27 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cathcor/LX/Desktop, System, X-Ray, Angiographic on 2002-11-27. The reason FDA records is "Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1032-03
Status: Terminated
Initiated: 2002-11-27
Posted: 2003-07-19
Terminated: 2006-10-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Cathcor/LX/Desktop, System, X-Ray, Angiographic
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
FDA root cause: Other
Action: A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.
Quantity in commerce: 9
Distribution: 5 Hospitals/Clinics in the US.
Product codes and lots: Serial Numbers:01029, 01033, 01034,01062, 01108, 01110, 01121, 01125, 02048.

Product code IZI

K002137Class IICathcor DesktopSiemens Elema AB / cleared 2000-10-05

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)