Z-0972-2017Class II

Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated...

Name: Z-0972-2017 Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-12-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-12-08 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane... on 2016-12-08. FDA classified it as Class II and gives the reason as "Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume...". 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-0972-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-08
Posted: 2017-01-09
Terminated: 2019-04-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q/Q.zen, Angiographic x-ray system Stand alone system 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: Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702. For questions regarding this recall call 610-448-6461.
Quantity in commerce: 1,500 distributed Worldwide
Distribution: Nationwide Distribution
Product codes and lots: Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0972-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0971-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09
Z-0972-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

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)