Lower risk Medical device recall · FDA · Published August 12, 2025

Siemens Artis Pheno X-Ray System Recall: Limited System Movements After Startup

Siemens recalls Artis Pheno X-ray systems with model 10849000 due to limited movements after startup. Affected units have specific serial numbers. Contact Siemens for details.

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

🇺🇸 FDA recall #Z-2529-2025Medical device Siemens ›

Lower-risk recall

Limited system movements after startup .

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling Artis Pheno X-ray systems with model number 10849000 because they may move too little after startup. This could cause issues during medical procedures. Affected units have specific serial numbers listed in the recall. Read more at govinfonow.com/recall/51637-siemens-artis-pheno-x-ray-system-recall-limited-system-movements.

Source Summary by GovInfoNow · govinfonow.com/recall/51637-siemens-artis-pheno-x-ray-system-recall-limited-system-movements · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2529-2025

Cite this page

“Siemens Artis Pheno X-Ray System Recall: Limited System Movements After Startup.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51637-siemens-artis-pheno-x-ray-system-recall-limited-system-movements. Based on FDA recall #Z-2529-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2529-2025%22&limit=1).

The FDA announced on Aug. 12, 2025, that Siemens Medical Solutions USA, Inc. is recalling Artis Pheno Image-Intensified Fluoroscopic X-Ray Systems due to limited system movements after startup. The recall affects 20 units distributed nationwide.

How to tell if you have it

Brand: Siemens
Product: Artis Pheno Image-Intensified Fluoroscopic X-Ray System
Model No.: 10849000
Serial Nos.: 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097
Quantity: 20 units

The hazard

The systems may experience limited movements after startup. The FDA classified this recall as Class II.

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 Philips Azurion 5 M12 X-ray System May Not Start Properly (March 3, 2026), Philips Azurion 7 B20 X-ray System May Not Start Properly (March 3, 2026), and Philips Azurion 3 M12 X-ray System May Not Start Properly (March 3, 2026).

How to tell if you have this one

Check for model number 10849000 and serial numbers listed in the recall (e.g., 164184, 164183, etc.). The system is sold by Siemens Medical Solutions USA, Inc.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model and Serial Numbers
Look for model number 10849000 and serial numbers listed in the recall (e.g., 164184, 164183, etc.).

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

FDA distribution: “US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Florida, Kentucky, Massachusetts, Michigan, New York, Oregon, Tennessee, Texas, Utah.

Recall timeline

FDA published this recall 36 days after the firm started it.

Aug 12, 2025Firm started the recall
Sep 5, 2025FDA classified it Class II
Sep 17, 2025Published in FDA’s Enforcement Report

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

What serial numbers are affected?

Affected serial numbers include 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097.

Similar recalls

Latest medical device recalls

Keep exploring

More Siemens recalls

Link to this recall

<a href="https://govinfonow.com/recall/51637-siemens-artis-pheno-x-ray-system-recall-limited-system-movements">Siemens Artis Pheno X-Ray System Recall: Limited System Movements After Startup (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-2529-2025 (August 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2529-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.