FDAClass II · Medical device · Recall Z-2648-2026 · Recalled July 8, 2026

ARTIS icono ceiling recall — Siemens Medical Solutions USA, Inc

Agency report date: July 8, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: ARTIS icono ceiling
Company / brand: Siemens Medical Solutions USA
Lot / serial / date codes: Model Number: 11328100. UDI-DI: 4056869295923.
Distribution: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.

Agency product description and boundaries

ARTIS icono ceiling. Model Number: 11328100.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

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

Affected product: ARTIS icono ceiling recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

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

Affected products

ARTIS icono ceiling recall status

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

Other medical device recalls from around the same time

Abiomed REF recall — Oscor Inc.FDA · July 22, 2026
Abiomed REF recall — Oscor Inc.FDA · July 22, 2026
Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves DivisionFDA · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 6, 2026 at 6:00 PM UTC.

Report a data error on this page