CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report

Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled

Siemens Medical Solutions USA is recalling Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic Axiom Artis zee and Q/Q.zen, distributed nationwide in the US. The recall was initiated on 18 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesArtis zee floor MN - Serial number: 140221 140226 140406

Quantity recalled986 units in 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-3096-2017
FDA event ID: 77908
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2016
FDA classified: 29 Aug 2017
Reported: 6 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Feb 2016	Recall initiated by company
29 Aug 2017	Classified by FDA	+558 days
6 Sep 2017	Published in enforcement report	+8 days

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

Reason for recall

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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-zee/zeego and 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 zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic Axiom Artis zee and Q/Q.zen recalled?

Yes. Siemens Medical Solutions USA recalled Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic Axiom Artis zee and Q/Q.zen on 18 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-3096-2017.

Why was it recalled?

Which lots are affected?

Artis zee floor MN - Serial number: 140221 140226 140406

Where was it sold?

Nationwide Distribution

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

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