CLASS II Device recall · Reported 26 Jul 2017 · FDA Enforcement Report

Artis zee,x-ray system, angiographic Artis zee is a family recalled

Siemens Medical Solutions USA is recalling Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography, distributed in 10 states. The recall was initiated on 3 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035

Quantity recalled97 distributed worldwide, 12 distributed in United States

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-2686-2017
FDA event ID: 77201
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2017
FDA classified: 14 Jul 2017
Reported: 26 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

3 Feb 2017	Recall initiated by company
14 Jul 2017	Classified by FDA	+161 days
26 Jul 2017	Published in enforcement report	+12 days

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

Reason for recall

Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.

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,x-ray system, angiographic Artis zee 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 Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis

Where it was distributed

Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY

Arkansas Iowa Illinois Kansas Michigan Minnesota New York Ohio Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.

Which lots are affected?

Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035

Where was it sold?

Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY

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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