Siemens Interventional Fluoroscopy System May Shut Down Randomly - Safety Recall
Siemens recalls certain interventional fluoroscopy systems that may randomly shut down due to UPS issues. Affected models include ARTIS Icono biplane and floor units. Consumers should contact Siemens for details.
Lower-risk recall
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Contact the company
What happened, in plain English
Siemens is recalling specific interventional fluoroscopy systems that may randomly shut down due to a UPS issue. This could disrupt medical procedures and affect patient care during imaging. Read more at govinfonow.com/recall/63196-siemens-interventional-fluoroscopy-system-may-shut-down-randomly-safety-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/63196-siemens-interventional-fluoroscopy-system-may-shut-down-randomly-safety-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1288-2021
Cite this page
“Siemens Interventional Fluoroscopy System May Shut Down Randomly - Safety Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63196-siemens-interventional-fluoroscopy-system-may-shut-down-randomly-safety-recall. Based on FDA recall #Z-1288-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1288-2021%22&limit=1).
Why it’s dangerous
The imaging system's UPS may cause the PC to shut down unexpectedly without a power issue. This could interrupt medical procedures and potentially delay critical patient care.
Who’s affected
Healthcare providers using the affected Siemens fluoroscopy systems are most at risk. Patients undergoing procedures with these systems may experience delays or interruptions.
How to tell if you have this one
Check for the ARTIS Icono biplane model (11327600) or floor model (11327700) in your facility. These systems were sold for interventional procedures and pediatric/obese patient imaging.
- Brand
Siemens- Category
Medical device
What to do — step by step
Contact Siemens
Reach out to Siemens Medical Solutions USA, Inc for specific guidance on the affected units and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of MI, KY, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Kentucky, Michigan, Texas.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-1288-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1288-2021 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.