CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report

Artis pheno and Artis Icono biplane, floor and ceiling recalled

Siemens Medical Solutions USA is recalling Artis pheno and Artis Icono biplane, floor and ceiling, distributed nationwide in the US. The recall was initiated on 10 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

Quantity recalledU.S. 758, OUS 2077

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-1653-2026
FDA event ID: 98675
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Mar 2026
FDA classified: 7 Apr 2026
Reported: 15 Apr 2026
Type: FDA Mandated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Mar 2026	Recall initiated by company
7 Apr 2026	Classified by FDA	+28 days
15 Apr 2026	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

During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

Product as listed by the FDA

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

Where was it sold?

Worldwide - 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.

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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide