Z-1945-2013Class II

Siemens AXIOM Artis zeego x-ray, angiographic system

Name: Z-1945-2013 Siemens AXIOM Artis zeego x-ray, angiographic system
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-05-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-05-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens AXIOM Artis zeego x-ray, angiographic system on 2013-05-13. FDA classified it as Class II and gives the reason as "Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system". 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-1945-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Posted: 2013-08-09
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens AXIOM Artis zeego x-ray, angiographic system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens, sent an "Important safety notice" by letter on May 13, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately notify the service department to clarify what further measures need to be taken, if after carrying out the regular brake test, the system can only be moved at a reduced speed. If this device has been sold and is therefore no longer in your possession, send this safety notice to the new owner and provide the new owner to Siemens. Update instruction AX012/13/S was issued, and a software update will be released as AX006/13/S and AX007/13/S which will modify the system software so that it will not be possible for information to be overlaid. If you have any questions call +49 (9191) 18 0.
Quantity in commerce: 132
Distribution: Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Model number 10280959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09

Product code IZI

K090745Class IIArtis Zee / Zeegos with Sw Vc14Siemens Medical Solutions USA, Inc. / cleared 2009-06-18

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)