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Lower risk Medical device recall · FDA · Published May 20, 2026

Siemens ARTIS icono floor recall: Risk of loss of movement capability

Siemens recalls ARTIS icono floor model 11327700 due to potential loss of movement capability after adjusting detector lift height to max or min limits. Affected units have specific serial numbers.

🇺🇸 FDA recall #Z-2643-2026Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling its ARTIS icono floor model 11327700 because adjusting the detector lift height to maximum or minimum limits can cause loss of movement capability. This could affect medical imaging equipment used in hospitals. Read more at govinfonow.com/recall/49140-siemens-artis-icono-floor-recall-risk-of-loss-of-movement.

Source Summary by GovInfoNow · govinfonow.com/recall/49140-siemens-artis-icono-floor-recall-risk-of-loss-of-movement · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2643-2026

Cite this page

“Siemens ARTIS icono floor recall: Risk of loss of movement capability.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49140-siemens-artis-icono-floor-recall-risk-of-loss-of-movement. Based on FDA recall #Z-2643-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2643-2026%22&limit=1).

Siemens Medical Solutions USA, Inc. recalled the ARTIS icono floor imaging system on May 20, 2026, according to the FDA. The device poses a potential loss of movement capability when adjusting detector lift height limits. Owners should contact Siemens for remedy details.

How to tell if you have it

  • Brand: Siemens
  • Product: ARTIS icono floor
  • 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
  • Units affected: 30
  • Distribution: US Nationwide

The hazard

The recall addresses the potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026), and Siemens ARTIS pheno and Icono Biplane X-Ray Recalls (March 10, 2026). Other recent recalls of similar products include Philips Azurion 3 M15 System Recall (Jan. 26, 2026), Philips Azurion 7 B20 System Recall (Jan. 26, 2026), and Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026).

How to tell if you have this one

Check for the model number 11327700 on the device. Affected units have specific serial numbers listed in the recall notice, including 174132, 174128, and others.

  • Brand
    Siemens
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2641-2026ARTIS icono biplane. Model Number: 11327600.; 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, 18410985 units
Z-2642-2026ARTIS icono ceiling. Model Number: 11328100.; Model Number: 11328100. UDI-DI: 4056869295923. Serial Numbers: 194180, 194184, 194169, 194101, 194131, 194223, 194193, 194216, 194215, 194080, 194186, 194164, 194102, 194054, 194181, 194185, 194194, 194188, 194095, 194094, 194093, 194090, 194086, 194203, 194037, 194116, 194114, 194207, 194209, 194120, 194177, 194036, 194038, 194213, 194103, 194190, 194096, 194139, 194165, 194066, 194210, 194098, 194221, 194072, 194047, 194212, 194226, 194197, 194141, 194039, 194088, 194204, 194113, 194222, 194083, 194128, 194219, 194146, 194145, 194099, 194205, 194200, 194081, 194082, 194218, 194147, 194189, 194109, 194183, 194187, 194105, 194119, 194201, 194050, 194049, 194174, 194199, 194079, 194135, 194085, 194125, 194034, 194121, 194111, 194158, 194092, 194133, 194220, 194192, 194071, 194136, 194182, 194161, 194162, 194211, 194127, 194126, 194124, 194123, 194122, 194108, 194175, 194035, 194225, 194149, 194107, 194208, 194104, 194089, 194227, 194041, 194040, 194173, 194179, 194163, 194172, 194143, 194117, 194144.119 units
Z-2643-2026ARTIS icono floor. Model Number: 11327700.; 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, 174067.30 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number 11327700 on the ARTIS icono floor device.

  2. Contact Manufacturer

    Contact Siemens Medical Solutions USA, Inc for specific guidance on affected units and next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: May 20, 202612. FDA classified it Class II: Jul 1, 202623. Published in FDA’s Enforcement Report: Jul 8, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2643-2026 (May 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2643-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA