Use cautionMedical device recall · FDA · Published March 26, 2021
Siemens Artis zee Fluoroscopy System Recall: Cable Abrasion Risk
Siemens recalls Artis zee ceiling-interventional fluoroscopy systems with model 10094137 due to cable abrasion at the inner C-arm outlet, potentially requiring treatment cancellation or switch to alternative systems.
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
“Siemens Artis zee Fluoroscopy System Recall: Cable Abrasion Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62906-siemens-artis-zee-fluoroscopy-system-recall-cable-abrasion-risk. Based on FDA recall #Z-1495-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1495-2021%22&limit=1).
The FDA announced on March 26, 2021, that Siemens Medical Solutions USA, Inc. is recalling the Artis zee ceiling-interventional Fluoroscopic X-Ray System due to potential cable abrasion that could interrupt clinical treatments. The agency issued recall number Z-1495-2021 for the device.
How to tell if you have it
Brand: Siemens
Product: Artis zee ceiling-interventional Fluoroscopic X-Ray System
Model Number: 10094137
Serial Numbers: 125000 through 125269, 146104 through 148522 (as listed in record)
Units affected: 772 units in the U.S.
The hazard
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm. The limited functionality may not be sufficient to continue with treatment as planned, which may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
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 the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS Icono Biplane Recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025), the GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), and the Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025).
How to tell if you have this one
Check for model number 10094137 on the system. Serial numbers listed in the recall include many numbers starting with 125000 through 148522.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Model
Verify the model number is 10094137 to confirm if your system is affected.
Contact Siemens
Reach out to Siemens Medical Solutions USA, Inc for further instructions on resolving the issue.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days 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-1495-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1495-2021 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.