Z-0972-2015Class II

Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated...

Name: Z-0972-2015 Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-12-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-12-03 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane... on 2014-12-03. FDA classified it as Class II and gives the reason as "Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure...". 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-0972-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Posted: 2015-01-14
Terminated: 2015-04-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is 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: Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an important customer safety information notice, dated December 3, 2014, to all affected customers. The letter identified the product, problem, and action to be taken. The following hardware modifications will be implemented with the corrective action AX042/14/S: 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area of the arc. In general all systems will be checked for existing damage prior to the implementation of this action. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 50
Distribution: Nationwide Distribution
Product codes and lots: model numbers: 10848281; 10848354

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0972-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0972-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

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)