Z-0172-2014Class II

Artis zee systems x-ray, angiographic system

Name: Z-0172-2014 Artis zee systems x-ray, angiographic system
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-01-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-01-21 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee systems x-ray, angiographic system on 2013-01-21. FDA classified it as Class II and gives the reason as "The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation...". 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-0172-2014
Classification: Class II
Status: Terminated
Initiated: 2013-01-21
Posted: 2013-11-14
Terminated: 2014-10-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee systems x-ray, angiographic system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an letter to all affected customers in January 2013, notifying them of the potential issue and urging customers to make appointments with Siemens to have software update AX 027/12/S realized in order to resolve the problem. The software update was made available from January 22, 2013, on. Customers were also asked to pass along this information if the device was no longer in their possession. The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 17 unit(s) will consist of the following: 1. The firm sent out a customer notification letter in January 2013 notifying them of the issue and highlighting the approved procedures of the Corrective Action Plan. 2. Siemens directed in the customer notification letter, for the end-user to make an appointment with the Customer Service organization to have safety update AX 027/12/S realized. 3. As stated in the safety update AX 027/12/S and in the e-mail response the update to correct this issue will be provided to the customer at no expense. 4. Siemens indicated in the customer notification letter that the AX 027/12/S update will be made available from January 22, 2013 and on. 5. The AX 027/12/S update provides general information, work instructions and a completion certificate on how to correct the dislocated scatter radiation filter inside the collimator. You may proceed with implementation of the CAP (subject to the conditions noted above). For further questions please call (610) 219-6300.
Quantity in commerce: 17
Distribution: US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Product codes and lots: model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0172-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0172-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

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)