CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report

Artis Zee Angiographic x-ray systems recalled

Siemens Medical Solutions USA is recalling Artis Zee Angiographic x-ray systems, distributed in 9 states. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled9

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-1309-2014
FDA event ID: 67558
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2014
FDA classified: 31 Mar 2014
Reported: 9 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

7 Feb 2014	Recall initiated by company
31 Mar 2014	Classified by FDA	+52 days
9 Apr 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

An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.

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 Angiographic x-ray systems.

Where it was distributed

MN, WI, PA, MI, AL, OH, NC, AR, and NJ.

Alabama Arkansas Michigan Minnesota North Carolina New Jersey Ohio Pennsylvania Wisconsin

Questions about this recall

Why was it recalled?

An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.

Which lots are affected?

Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.

Where was it sold?

MN, WI, PA, MI, AL, OH, NC, AR, and NJ.

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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