FDAFDA recall Z-2641-2026 · Jul 8, 2026
Siemens Medical Solutions USA, Inc: ARTIS icono biplane recall
Recall found
Product
ARTIS icono biplane. Model Number: 11327600.
Reason for recall
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 85 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-20
Source: openFDA enforcement record Z-2641-2026 · search recall number Z-2641-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.