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Use caution Medical device recall · FDA · Published June 8, 2026

Siemens ARTIS icono Ceiling Monitor Recall: Loose Screws Risk Falling

Siemens recalls ARTIS icono ceiling monitors (model 11328100) due to screws loosening over time, potentially causing the monitor to fall. Affected units may need repair or replacement.

🇺🇸 FDA recall #Z-2648-2026Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling ARTIS icono ceiling monitors with model number 11328100 because screws holding the monitor to its suspension can gradually loosen. This could cause the monitor to fall, which might lead to injury or damage. Read more at govinfonow.com/recall/49035-siemens-artis-icono-ceiling-monitor-recall-loose-screws-risk-falling.

Source Summary by GovInfoNow · govinfonow.com/recall/49035-siemens-artis-icono-ceiling-monitor-recall-loose-screws-risk-falling · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2648-2026

Cite this page

“Siemens ARTIS icono Ceiling Monitor Recall: Loose Screws Risk Falling.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49035-siemens-artis-icono-ceiling-monitor-recall-loose-screws-risk-falling. Based on FDA recall #Z-2648-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2648-2026%22&limit=1).

The FDA announced on June 8, 2026, that Siemens Medical Solutions USA, Inc. is recalling the ARTIS icono ceiling medical device due to a potential hazard with its display ceiling suspension. The agency issued recall number Z-2648-2026 for the voluntary Class II action affecting 57 units distributed nationwide.

How to tell if you have it

  • Brand: Siemens
  • Product: ARTIS icono ceiling
  • Model Number: 11328100
  • UDI-DI: 4056869295923

The hazard

The recall addresses a potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time, some screws that keep the monitor attached to the suspension may gradually loosen.

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 floor recall (May 20, 2026), Siemens ARTIS Pheno VE30A/VE40A (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 System Recall (March 31, 2026), Canon Alphenix X-ray Systems Recall (August 4, 2026), and Canon Alphenix INFX-8000V X-ray System Recall (December 19, 2025).

How to tell if you have this one

Check for the model number 11328100 on the monitor. The recall applies to units sold with UDI-DI: 4056869295923.

  • Brand
    Siemens
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Monitor Stability

    Ensure the monitor is securely attached to the ceiling suspension. If it feels loose, stop using it immediately.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Indiana, Iowa, Louisiana, Missouri, New York, North Carolina, Pennsylvania, South Carolina.

Recall timeline

FDA published this recall 30 days after the firm started it.

1. Firm started the recall: Jun 8, 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-2648-2026 (June 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2648-2026 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