Z-1446-04

AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637

Name: Z-1446-04 AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-05-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-05-17 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 on 2004-05-17. The reason FDA records is "Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1446-04
Status: Terminated
Initiated: 2004-05-17
Posted: 2004-09-14
Terminated: 2005-04-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed to correct the problem.
Quantity in commerce: 234 units
Distribution: The product was shipped to 43 medical facilities nationwide and one government account in KY.
Product codes and lots: Serial Numbers 1002, 1034, 1100-1253, 1300-1504

Product code DQK

K020440Class IINewcorSiemens Medical Systems, Inc. / cleared 2002-12-03

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)