Z-2686-2017Class II

Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for...

Name: Z-2686-2017 Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-02-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-02-03 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and... on 2017-02-03. FDA classified it as Class II and gives the reason as "Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit". 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-2686-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-03
Posted: 2017-07-14
Terminated: 2017-10-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee,x-ray system, angiographic 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. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Root cause tag: design
FDA root cause: Component design/selection
Action: CDRH approved the CAP subject to the following conditions: 1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. 2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.
Quantity in commerce: 97 distributed worldwide, 12 distributed in United States
Distribution: Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Product codes and lots: Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2686-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2686-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-14

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)