Z-0128-2009

Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392

Name: Z-0128-2009 Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-09-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-09-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392 on 2008-09-02. The reason FDA records is "Incorrect contour finding: Image may be calibrated to the wrong size catheter". 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-0128-2009
Status: Terminated
Initiated: 2008-09-02
Posted: 2008-11-25
Terminated: 2009-10-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
Quantity in commerce: 46 units
Distribution: Nationwide.
Product codes and lots: Model number 7728392. Serial numbers: 44075, 44077, 44084, 44240, 44262, 44265, 44267, 44268, 44269, 44270, 44271, 44272, 44273, 44274, 44275, 44276, 44277, 44278, 44279, 44280, 44281, 44282, 44283, 44284, 44285, 44286, 44287, 44288, 44289, 44290, 44291, 44292, 44293, 44294, 44295, 44296, 44298, 44299, 44300, 44302, 44303, 44304, 44305, 44306, 44307, and 44308.

Product code IZI

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)