Z-0601-2017Class II

Artis Q, Angiographic x-ray system

Name: Z-0601-2017 Artis Q, Angiographic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-11-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-11-01 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic... on 2016-11-01. FDA classified it as Class II and gives the reason as "The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times". 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-0601-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-01
Posted: 2016-11-17
Terminated: 2017-06-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of 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 with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken.
Quantity in commerce: 4,657 systems (worldwide)
Distribution: US Nationwide Distribution.
Product codes and lots: Model Numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0601-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0601-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0602-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0603-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

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)