FDAClass II · Medical device · Recalled July 8, 2026

ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2648-2026
Brand: Siemens Medical Solutions USA
Classification: Class II
Units affected: 57 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

ARTIS icono ceiling. Model Number: 11328100.

Affected products

ARTIS icono ceiling

Companies & origin

Recalling firm location: Malvern, PA, United States
Firm address: 40 Liberty Blvd, N/A, 19355-1418

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: 11328100. UDI-DI: 4056869295923.
Distribution: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99224
Recall initiated: June 8, 2026
FDA classified: July 1, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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