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Class IIOngoingUpdated Nov 2, 2026

Siemens Medical Solutions USA, Inc recalls 2 products

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Siemens Medical Solutions USA, Inc
Reason
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99079…

Products (2)

  1. ARTIS icono biplane. Model Number: 11327600.

    Codes/lots: Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 1Quantity: 85 unitsRecall no. Z-2641-2026Class II
  2. ARTIS icono floor. Model Number: 11327700.

    Codes/lots: Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067.Quantity: 30 unitsRecall no. Z-2643-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.
  2. Product details, codes or quantities changed; Units: 85 units; 119 units; 30 units → 85 units; 30 units

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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