CLASS II Device recall · Reported 25 Feb 2015 · FDA Enforcement Report

Artis One; The Artis One is an angiography system developed recalled

Siemens Medical Solutions USA is recalling Artis One; The Artis One is an angiography system developed for diagnostic interventional, distributed nationwide in the US. The recall was initiated on 16 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 10848600, serial number 82010

Quantity recalled1

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-1119-2015
FDA event ID: 70342
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2015
FDA classified: 17 Feb 2015
Reported: 25 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

16 Jan 2015	Recall initiated by company
17 Feb 2015	Classified by FDA	+32 days
25 Feb 2015	Published in enforcement report	+8 days

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

Reason for recall

The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Product as listed by the FDA

Artis One; The Artis One is an angiography system developed for diagnostic 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. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

Where it was distributed

Nationwide Distribution to MI only

Nationwide Michigan

Questions about this recall

Why was it recalled?

The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Which lots are affected?

Model Number 10848600, serial number 82010

Where was it sold?

Nationwide Distribution to MI 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 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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