Z-2587-2014Class II

AXIOM Artis or Artis zee system

Name: Z-2587-2014 AXIOM Artis or Artis zee system
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-06-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-06-05 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic... on 2014-06-05. FDA classified it as Class II and gives the reason as "There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image". 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-2587-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Posted: 2014-09-24
Terminated: 2015-04-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
Product code: IZI System, X-Ray, Angiographic
Reason for recall: There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Important Safety Information letter dated June 5, 2014, to affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to observe this safety notice and comply with the corresponding measures until the update has been fully completed.
Quantity in commerce: 1067
Distribution: US Nationwide Distribution.
Product codes and lots: material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2587-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2587-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

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