Z-0035-05

AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Name: Z-0035-05 AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-07-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-07-09 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658 on 2004-07-09. The reason FDA records is "possible error calculating valve area with the AXIOM Sensis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0035-05
Status: Terminated
Initiated: 2004-07-09
Posted: 2004-10-22
Terminated: 2005-09-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: possible error calculating valve area with the AXIOM Sensis
FDA root cause: Other
Action: The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
Quantity in commerce: 143 units
Distribution: The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.
Product codes and lots: Serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055.

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)