Z-1750-2013Class II

Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus

Name: Z-1750-2013 Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-01-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-01-31 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system on 2013-01-31. FDA classified it as Class II and gives the reason as "During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail". 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-1750-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-31
Posted: 2013-07-17
Terminated: 2014-11-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013.
Quantity in commerce: 23
Distribution: United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
Product codes and lots: Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1750-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1750-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-17

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)