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ARTIS icono biplane. Model Number: 11327600.

Class II
Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Affected products (lot / model / serial)
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
Units affected
85 units
Distribution pattern
US Nationwide distribution.
Firm location
Malvern, PA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2641-2026
Recall initiated
May 20, 2026
FDA classification date
July 1, 2026
FDA report date
July 8, 2026
FDA event ID
99079
Last updated on HTM Vibe
July 23, 2026
View on openFDA