CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report

Artis Q And Q.Zen- Modular Angiographic System recalled

Siemens Medical Solutions USA is recalling Artis Q And Q.Zen- Modular Angiographic System, interventional fluoroscopic x-ray, distributed nationwide in the US. The recall was initiated on 13 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled11,111, worldwide and 3,187 in the USA

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2395-2016
FDA event ID: 74716
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2016
FDA classified: 11 Aug 2016
Reported: 17 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

13 Jul 2016	Recall initiated by company
11 Aug 2016	Classified by FDA	+29 days
17 Aug 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 74716

Reported	Class	Recall	Company	Reason	Where
17 Aug 2016	CLASS II	Artis Zee And Zeego, system, x-ray recalled	Siemens Medical Solutions USA	Other	Nationwide
17 Aug 2016	CLASS II	Axiom Artis Modular Angiography System, system, x-ray recalled	Siemens Medical Solutions USA	Other	Nationwide

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