CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report

Artis pheno recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis pheno. The recall was initiated on 9 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 4056869046877

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-2205-2026
FDA event ID: 98992
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Mar 2026
FDA classified: 4 Jun 2026
Reported: 10 Jun 2026
Type: FDA Mandated
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

9 Mar 2026	Recall initiated by company
4 Jun 2026	Classified by FDA	+87 days
10 Jun 2026	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

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Product as listed by the FDA

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Where it was distributed

US and Worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 4056869046877

Where was it sold?

US and Worldwide

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 98992

This product is part of a recall event; the main page for the event is Artis Icono biplane, floor and ceiling.: Artis icono biplane recalled.

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026	CLASS II	Artis Icono biplane, floor and ceiling.: Artis icono biplane recalled	Siemens Medical Solutions USA	Other	PA

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 Icono biplane, floor and ceiling.: Artis icono biplane recalled	Siemens Medical Solutions USA	Other	PA

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide