Z-1272-2014Class II

AXIOM Artis Systems

Name: Z-1272-2014 AXIOM Artis 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 AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and... on 2014-02-07. FDA classified it as Class II and gives the reason as "Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out 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-1272-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-03-22
Terminated: 2014-12-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0.
Quantity in commerce: 37
Distribution: USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
Product codes and lots: Model nos. 7412807, 7727717, 7728392 with serial numbers: 35020, 34999,35098 35113 35042 35061 35064 35073 35014 35069 35053 35055 35056 35054 35008 35057 35044 35018 35097 35108 35046 35048 35050 35045 35004 35019 46004 46005 40000 40009 40011 40006 40007 40010 44016 44005 44011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1272-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1272-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21

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)