Z-1309-2014Class II

Artis Zee Angiographic x-ray systems

Name: Z-1309-2014 Artis Zee Angiographic x-ray systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-02-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-02-07 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Zee Angiographic x-ray systems on 2014-02-07. FDA classified it as Class II and gives the reason as "An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1309-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-03-31
Terminated: 2015-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Zee Angiographic x-ray systems.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
Root cause tag: design
FDA root cause: Device Design
Action: A recall notification letter dated February 7, 2014, was sent to End Users.
Quantity in commerce: 9
Distribution: MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
Product codes and lots: Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1309-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1309-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-03-31

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)