CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

Artis icono ceiling recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis icono ceiling, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 11328100. UDI-DI: 4056869295923.

Quantity recalled57 units

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-2648-2026
FDA event ID: 99224
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jun 2026
FDA classified: 1 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jun 2026	Recall initiated by company
1 Jul 2026	Classified by FDA	+23 days
8 Jul 2026	Published in enforcement report	+7 days

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

Reason for recall

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

Product as listed by the FDA

ARTIS icono ceiling. Model Number: 11328100.

Where it was distributed

US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.

Nationwide California Georgia Iowa Indiana Louisiana Missouri North Carolina New York Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

Which lots are affected?

Model Number: 11328100. UDI-DI: 4056869295923.

Where was it sold?

US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.

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
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA
10 Jun 2026Device	CLASS II	Artis Icono biplane, floor and ceiling.: Artis icono biplane recalled	Siemens Medical Solutions USA	Other	PA

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