Z-1824-2017Class II

Artis zee, Angiographic x-ray system

Name: Z-1824-2017 Artis zee, Angiographic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-03-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-03-28 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee, Angiographic x-ray system on 2017-03-28. FDA classified it as Class II and gives the reason as "Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1824-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Posted: 2017-03-30
Terminated: 2017-08-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee, Angiographic x-ray system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens mailed a Customer Safety Advisory Notice (CSAN) AX017/17/S to affected customers on 03/28/2017 to inform them of the corrective action that will be performed to prevent a possible hazard to persons and equipment. The notice also explained the underlying issue, the impact on system operation, potential risk to patients and actions they are taking to correct the issue.
Quantity in commerce: 3 units distributed in U.S.
Distribution: Distributed to: VA, CA, WI
Product codes and lots: Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1824-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-14

Product code IZI

K073290Class IIArtis Zee and ZeegoSiemens Medical Solutions USA, Inc. / cleared 2008-02-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)