CLASS II Device recall · Reported 5 Mar 2014 · FDA Enforcement Report

Siemens Artis zee Ceiling Systems recalled

Siemens Medical Solutions USA is recalling Siemens Artis zee Ceiling Systems, distributed nationwide in the US. The recall was initiated on 16 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesArtis zee Ceiling systems serial numbers from 146352 to 147617

Quantity recalled284

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-1080-2014
FDA event ID: 67175
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 16 Dec 2013
FDA classified: 24 Feb 2014
Reported: 5 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

16 Dec 2013	Recall initiated by company
24 Feb 2014	Classified by FDA	+70 days
5 Mar 2014	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

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Siemens Artis zee Ceiling Systems recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Artis zee Ceiling Systems on 16 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-1080-2014.

Why was it recalled?

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

Which lots are affected?

Artis zee Ceiling systems serial numbers from 146352 to 147617

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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