CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report

Artis Pheno Interventional Fluoroscopic X-Ray System recalled

Siemens Medical Solutions USA is recalling Artis Pheno Interventional Fluoroscopic X-Ray System, distributed nationwide in the US. The recall was initiated on 29 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes164013 164011

Quantity recalled429 total

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-3190-2018
FDA event ID: 80905
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jul 2018
FDA classified: 18 Sep 2018
Reported: 26 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Imaging Equipment

Timeline

29 Jul 2018	Recall initiated by company
18 Sep 2018	Classified by FDA	+51 days
26 Sep 2018	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

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

164013 164011

Where was it sold?

US 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 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.

Other products in this recall event

1 other product · FDA event 80905

Reported	Class	Recall	Company	Reason	Where
26 Sep 2018	CLASS II	Artis Q Interventional Fluoroscopic X-Ray System recalled	Siemens Medical Solutions USA	Temperature Abuse	Nationwide

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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