Use caution Medical device recall · FDA · Published September 21, 2020

Siemens Artis One Systems Recall: Display Monitor May Malfunction During X-Ray

Siemens recalls Artis One systems with specific model numbers due to potential display monitor issues during X-ray procedures. Affected units may show no display, flickering, or incorrect resolution.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0298-2021Medical device Siemens ›

Use caution until it’s fixed

Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355

✎ GovInfoNow plain-language explainer

Siemens is recalling Artis One X-ray systems with model number 10848600 because the display monitor can become intermittently dysfunctional during use. This could lead to incorrect imaging results or safety issues for patients and staff. Read more at govinfonow.com/recall/64255-siemens-artis-one-systems-recall-display-monitor-may-malfunction-during.

Source Summary by GovInfoNow · govinfonow.com/recall/64255-siemens-artis-one-systems-recall-display-monitor-may-malfunction-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0298-2021

Cite this page

“Siemens Artis One Systems Recall: Display Monitor May Malfunction During X-Ray.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64255-siemens-artis-one-systems-recall-display-monitor-may-malfunction-during. Based on FDA recall #Z-0298-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0298-2021%22&limit=1).

The FDA announced on September 21, 2020, that Siemens Medical Solutions USA, Inc. is recalling Siemens Artis one fluoroscopic X-ray systems due to a potential display malfunction hazard. The agency issued recall number Z-0298-2021 for the Class II device.

How to tell if you have it

Brand: Siemens
Product: Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System
Model: 10848600
Serial Numbers: 82010, 82038, 82039, 82040, 82044, 82054, 82065, 82066, 82070, 82102, 82105, 82108, 82109, 82205, 82213, 82217, 82267, 82308, 82354, 82355, 82378, 82383
Units affected: 22

The hazard

According to the FDA, the recall addresses a potential malfunction in which the examination room monitor may become intermittently dysfunctional. This issue can manifest as no display, flickering, or wrong resolution.

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 ceiling recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), the Philips Azurion X-Ray System Recall (June 17, 2026), and the GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026).

How to tell if you have this one

Check for the model number 10848600 on the system. Affected units were sold with specific serial numbers listed in the recall notice.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Display Function
Ensure the monitor shows a stable image without flickering or incorrect resolution during X-ray procedures.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 15 states.

FDA distribution: “US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Indiana, Louisiana, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Texas, Washington.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

Sep 21, 2020Firm started the recall
Oct 27, 2020FDA classified it Class II
Nov 4, 2020Published in FDA’s Enforcement Report
Aug 3, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if my system is affected?

Check the serial numbers listed in the recall: 82010, 82038, 82039, 82040, 82044, 82054, 82065, 82066, 82070, 82102, 82105, 82108, 82109, 82205, 82213, 82217, 82267, 82308, 82354, 82355, 82378, 82383.

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Link to this recall

<a href="https://govinfonow.com/recall/64255-siemens-artis-one-systems-recall-display-monitor-may-malfunction-during">Siemens Artis One Systems Recall: Display Monitor May Malfunction During X-Ray (GovInfoNow)</a>

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-0298-2021 (September 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0298-2021 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.