Lower risk Medical device recall · FDA · Published November 30, 2020

Siemens Artis zee/zeego & Artis Q/Q.zen: Risk of Excessive Radiation During Frame Rate

Siemens recalls Artis zee, zeego, Q, and Q.zen models due to potential radiation levels exceeding safety limits when switching frame rates during fluoroscopy. Affected units may require repair or replacement.

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

🇺🇸 FDA recall #Z-0656-2021Medical device Siemens ›

Lower-risk recall

When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens is recalling several medical imaging devices because changing frame rates during fluoroscopy can cause radiation levels to exceed safety limits. This could lead to unnecessary radiation exposure for patients or staff if the device is used without correction. Read more at govinfonow.com/recall/63760-siemens-artis-zee-zeego-artis-q-q-zen-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/63760-siemens-artis-zee-zeego-artis-q-q-zen-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0656-2021

Cite this page

“Siemens Artis zee/zeego & Artis Q/Q.zen: Risk of Excessive Radiation During Frame Rate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63760-siemens-artis-zee-zeego-artis-q-q-zen-risk-of. Based on FDA recall #Z-0656-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0656-2021%22&limit=1).

The FDA announced on November 30, 2020, that Siemens Medical Solutions USA, Inc. is recalling Artis zee, zeego, Q, Q.zen, and Pheno medical imaging devices because the measured Air Kerma Rate can exceed regulatory limits during specific Fluoro Override operations. Owners should contact Siemens for remedy details.

How to tell if you have it

Brand: Siemens
Product names: Artis zee, zeego, Q, Q.zen, Pheno
Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10849000, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355
Quantity: 5602 units

The hazard

According to the FDA, when users change frame rates from lower frequency (e.g., 10 f/s) to higher frequency (e.g., 30 f/s) during continuous release of Fluoro "Fluoro Override," the measured Air Kerma Rate can exceed regulatory limits.

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 AGFA DR 800 X-Ray System Recall (November 18, 2025), Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026), and Canon Alphenix INFX-8000H X-ray System Recall (December 19, 2025).

How to tell if you have this one

Check for model numbers listed: Artis zee floor (10094135), ceiling (10094137), multi-purpose (10094139), biplane (10094141), zeego (10280959), Pheno (10849000), Q floor (10848280), ceiling (10848281), biplane (10848282), zeego (10848283), Q.zen floor (10848353), ceiling (10848354), biplane (10848355).

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify your device model by checking the serial numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide-US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 51 days after the firm started it.

Nov 30, 2020Firm started the recall
Jan 11, 2021FDA classified it Class II
Jan 20, 2021Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63760-siemens-artis-zee-zeego-artis-q-q-zen-risk-of">Siemens Artis zee/zeego &amp; Artis Q/Q.zen: Risk of Excessive Radiation During Frame Rate (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-0656-2021 (November 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0656-2021 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.