CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report

Artis One, Interventional, Fluoroscopic recalled

Siemens Medical Solutions USA is recalling Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system, distributed nationwide in the US. The recall was initiated on 11 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # 82010, material # 10848600

Quantity recalled1 angiography system

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-1282-2016
FDA event ID: 73606
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2016
FDA classified: 31 Mar 2016
Reported: 6 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

11 Mar 2016	Recall initiated by company
31 Mar 2016	Classified by FDA	+20 days
6 Apr 2016	Published in enforcement report	+6 days

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

Reason for recall

After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.

Product as listed by the FDA

Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.

Where it was distributed

Nationwide Distribution to Michigan only

Nationwide Michigan

Questions about this recall

Is Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system recalled?

Yes. Siemens Medical Solutions USA recalled Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system on 11 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1282-2016.

Why was it recalled?

Which lots are affected?

Serial # 82010, material # 10848600

Where was it sold?

Nationwide Distribution to Michigan only

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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