Lower riskMedical device recall · FDA · Published October 21, 2020
Siemens Artis X-Ray Systems Recall: Overvoltage Risk
Siemens recalls Artis zee floor, Artis Q ceiling, and Artis Q.zen ceiling X-ray systems due to potential overvoltage issues. Affected units may malfunction during electrical surges.
Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer
Siemens is recalling certain Artis zee floor, Artis Q ceiling, and Artis Q.zen ceiling X-ray systems because faulty electronic components could cause malfunctions during electrical overvoltage events. This risk could lead to improper system operation if an electrical surge occurs. Read more at govinfonow.com/recall/64067-siemens-artis-x-ray-systems-recall-overvoltage-risk.
“Siemens Artis X-Ray Systems Recall: Overvoltage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64067-siemens-artis-x-ray-systems-recall-overvoltage-risk. Based on FDA recall #Z-0469-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0469-2021%22&limit=1).
The FDA announced on Oct. 21, 2020, that Siemens Medical Solutions USA, Inc. is recalling Artis zee floor, Artis Q ceiling, and Artis Q.zen ceiling Image-Intensified Fluoroscopic X-Ray Systems due to an inadequate overvoltage protection hazard. The agency issued recall number Z-0469-2021 for the voluntary Class II action.
How to tell if you have it
Brand: Siemens
Product: Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling Image-Intensified Fluoroscopic X-Ray System
Material numbers: 10848281, 10848354, 10094135
Serial numbers: 109762, 111158, 124344, 111161
The hazard
Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar product recalls include GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall (April 20, 2026), GE Allia Moveo X-ray System Recall (April 20, 2026), and GE Medical Systems Allia IGS Pulse X-ray System Recall (April 20, 2026).
How to tell if you have this one
Check for material numbers 10848281, 10848354, 10094135, or 10848354. Affected units were sold with serial numbers 109762, 111158, 124344, or 111161.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Material Numbers
Verify if your system has material numbers 10848281, 10848354, 10094135, or 10848354.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Illinois, Iowa.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Check your material numbers and serial numbers to see if your system is affected. The recall does not require immediate action but should be addressed if the system is confirmed affected.
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-0469-2021 (October 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0469-2021 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.