CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report

Artis zee/zeego, Angiographic x-ray system recalled

Siemens Medical Solutions USA is recalling Artis zee/zeego, Angiographic x-ray system, distributed nationwide in the US. The recall was initiated on 1 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Quantity recalled4,657 systems Worldwide

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-0602-2017
FDA event ID: 75606
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Nov 2016
FDA classified: 16 Nov 2016
Reported: 23 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

1 Nov 2016	Recall initiated by company
16 Nov 2016	Classified by FDA	+15 days
23 Nov 2016	Published in enforcement report	+7 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 that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Artis zee/zeego, 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.

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

Which lots are affected?

Model Numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Where was it sold?

US 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 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 75606

This product is part of a recall event; the main page for the event is Artis Q, Angiographic x-ray system recalled.

Reported	Class	Recall	Company	Reason	Where
23 Nov 2016	CLASS II	Artis Q, Angiographic x-ray system recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide
23 Nov 2016	CLASS II	Axiom Artis, Angiographic x-ray system recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
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8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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