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CLASS II · ModerateFDA

Siemens Medical Solutions USA, Inc recalls ARTIS icono biplane.

📅 May 20, 2026 · 📍 Nationwide
Recalling company
Siemens Medical Solutions USA, Inc
Product
ARTIS icono biplane. Model Number: 11327600.
Reason
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 20, 2026
Reported
Jul 8, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
85 units
Lot / codes
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, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109
Company location
Malvern, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-2641-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2641-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.