CLASS II Device recall · Reported 31 Jul 2013 · FDA Enforcement Report

Artis zee and zeego x-ray, angiographic system recalled

Siemens Medical Solutions USA is recalling Artis zee and zeego x-ray, angiographic system, distributed nationwide in the US. The recall was initiated on 26 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel numbers: 10094137, 10094139, 10094141, 10280959

Quantity recalled29

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-1782-2013
FDA event ID: 65651
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2013
FDA classified: 22 Jul 2013
Reported: 31 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

26 Jun 2013	Recall initiated by company
22 Jul 2013	Classified by FDA	+26 days
31 Jul 2013	Published in enforcement report	+9 days

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

Reason for recall

Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui

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 and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system

Where it was distributed

Nationwide Distribution and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Model numbers: 10094137, 10094139, 10094141, 10280959

Where was it sold?

Nationwide Distribution and Puerto Rico

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.

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