Z-2569-2014Class II

Artis zee and Artis zeego systems. x-ray, angiographic system

Name: Z-2569-2014 Artis zee and Artis zeego systems. x-ray, angiographic 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: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee and Artis zeego systems. x-ray, angiographic system on 2014-06-05. FDA classified it as Class II and gives the reason as "There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can...". 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-2569-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Posted: 2014-09-22
Terminated: 2015-04-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee and Artis zeego systems. x-ray, angiographic system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an "Important Customer Safety Notice" dated August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please forward this Safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this safety notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this Customer Safety Notice and comply with the corresponding measures until the update has been fully completed. For further questions please call (610) 219-6300.
Quantity in commerce: 206
Distribution: Nationwide Distribution
Product codes and lots: running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2569-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2569-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

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)