Z-2395-2016Class II

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis...

Name: Z-2395-2016 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-07-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-07-13 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of... on 2016-07-13. FDA classified it as Class II and gives the reason as "The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2395-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-13
Posted: 2016-08-11
Terminated: 2017-11-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen 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 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
FDA root cause: Under Investigation by firm
Action: Siemens has implemented a Customer Safety advisory Notice to all affected customer via Update Instruction AX007/15/S. Additional, a corrective action will be implemented via Update Instructions AX006/15/S and AX003/16/S.
Quantity in commerce: 11,111, worldwide and 3,187 in the USA
Distribution: Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam
Product codes and lots: Model Numbers:10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, 7728392

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2395-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2393-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11
Z-2394-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11
Z-2395-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code IZI

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)