Z-0979-03

Axiom Sensis. Programmable Diagnostic Computer

Name: Z-0979-03 Axiom Sensis. Programmable Diagnostic Computer
Creator: Siemens Medical Solutions USA, Inc
Published: 2003-02-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-02-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Sensis. Programmable Diagnostic Computer on 2003-02-28. The reason FDA records is "software problem - erroneous results or system crashes". 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-0979-03
Status: Terminated
Initiated: 2003-02-28
Posted: 2003-07-03
Terminated: 2004-04-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Sensis. Programmable Diagnostic Computer
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: software problem - erroneous results or system crashes
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued a Customer Safety Advisory Letter to their customers. The letter instructed the customer to insert the letter into their operator''s manual and that updated software would be released in May 2003.
Quantity in commerce: 4 units
Distribution: The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
Product codes and lots: Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.

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)