Z-2341-2015Class II

Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and...

Name: Z-2341-2015 Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-06-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-06-29 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to... on 2015-06-29. FDA classified it as Class II and gives the reason as "The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries...". 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-2341-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Posted: 2015-08-05
Terminated: 2016-12-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
Root cause tag: design
FDA root cause: Device Design
Action: A customer safety notice, dated June 29, 2015, was sent to direct accounts to alert them about the issue and that Siemens' service organization will be contacting them to perform the corrective action.
Distribution: US Nationwide
Product codes and lots: Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2341-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2341-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2342-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05

Product code OWB

K123529Class IIArtis Q and Q.zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2013-02-26

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)