Z-1202-2014Class II

Siemens Artis Q and Artis Q biplane systems

Name: Z-1202-2014 Siemens Artis Q and Artis Q biplane systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-12-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-12-05 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray on 2013-12-05. FDA classified it as Class II and gives the reason as "There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40)". 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-1202-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Posted: 2014-03-27
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.
Quantity in commerce: 19
Distribution: USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
Product codes and lots: model numbers 10848280, 10848281, 10848282, and 10848283.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1202-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1202-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27

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)