Use cautionMedical device recall · FDA · Published October 17, 2023
Siemens ARTIS icono X-ray System Recall: False Collision Signals After Power Off
Siemens recalls ARTIS icono ceiling x-ray systems with model 11328100 due to false collision signals after power off, risking temporary system unavailability during procedures.
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens ARTIS icono X-ray System Recall: False Collision Signals After Power Off.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57059-siemens-artis-icono-x-ray-system-recall-false-collision-signals. Based on FDA recall #Z-0523-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0523-2024%22&limit=1).
The FDA announced on Oct. 17, 2023, that Siemens Medical Solutions USA, Inc. is recalling the ARTIS icono fluoroscopic x-ray system due to a potential hardware issue. The hazard involves collision sensors falsely signaling non-existing collisions when the system is switched off for extended periods.
How to tell if you have it
Brand: Siemens
Product: ARTIS icono (ceiling configuration), Fluoroscopic x-ray system
Model no.: 11328100
UDI-DI: 04056869295923
Serial Numbers: All SN's associated with material number 11328100
The hazard
The collision sensor may falsely signal non-existing collisions for up to half an hour after the system is switched on following a longer shutdown. During this period, system movement is only possible with the "override" function at very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
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 icono ceiling recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), Philips Azurion 5 M12 X-ray System May Not Start Properly - Recall (March 3, 2026), and Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025).
How to tell if you have this one
Check for the model number 11328100 on the system. The recall includes all units with this model number and associated serial numbers.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Status
Verify if the system has been turned off for extended periods and then turned back on, which may trigger false collision signals.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Montana, Pennsylvania, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0523-2024 (October 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0523-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.