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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
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 23, 2026 at 11:04 PM UTC.
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