Z-0992-2013Class II

Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific...

Name: Z-0992-2013 Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-11-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-11-26 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system on 2012-11-26. FDA classified it as Class II and gives the reason as "In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction...". 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-0992-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-26
Posted: 2013-03-25
Terminated: 2013-12-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Customer Information letter dated November 8, 2012 to affected consignees. The letter notified consignees of the issue and informed them the update AX039/12/S would be started and affected systems would be checked and corrected if required. Customers were instructed that they would be contacted to arrange a date for checking their system. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 52
Distribution: Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, LA, MD, MI, MO, NC, NH, OR, PA, SD, TN, TX, WA and WI and Puerto Rico.
Product codes and lots: Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506, 160142, 160801, 160486, 160431, 160100, 160814, 160391, 160008, 160411, 160438, 160450, 160149, 160830, 160483, 160813, 160460, 160485, 160443, 160122, 160401, 160494, 160507, 160007, 160001, 160825, 160508, 160482, 160505, 160322, 160323, 160382, 160421, 160129, 160357, 160498, 160413, 160414, 160373, 160509, 160817, 160101 and 160469.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0992-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)