Lower risk Medical device recall · FDA · Published January 2, 2025

Siemens ARTIS One X-Ray System Recall: Incorrect Radiation Dose Risk

Siemens recalls ARTIS One Angiographic X-Ray Systems due to rare risk of higher radiation dose from incorrect copper prefiltration during x-ray releases. Affected units may require correction to prevent unintended radiation exposure.

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

🇺🇸 FDA recall #Z-0922-2025Medical device Siemens ›

Lower-risk recall

A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.

Take action

Contact the company

Recalling firmSIEMENS MEDICAL SOLUTIONS USA, INC40 Liberty Blvd · Malvern, Germany

✎ GovInfoNow plain-language explainer

Siemens is recalling its ARTIS One Angiographic X-Ray Systems because a rare issue could cause higher radiation doses during x-ray releases. This might lead to unintended radiation exposure for patients if the system malfunctions. Read more at govinfonow.com/recall/53158-siemens-artis-one-x-ray-system-recall-incorrect-radiation-dose.

Source Summary by GovInfoNow · govinfonow.com/recall/53158-siemens-artis-one-x-ray-system-recall-incorrect-radiation-dose · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0922-2025

Cite this page

“Siemens ARTIS One X-Ray System Recall: Incorrect Radiation Dose Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53158-siemens-artis-one-x-ray-system-recall-incorrect-radiation-dose. Based on FDA recall #Z-0922-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0922-2025%22&limit=1).

The FDA announced on Jan. 2, 2025, that Siemens Medical Solutions USA, Inc. is recalling the ARTIS One Angiographic X-Ray System due to a potential issue with incorrect copper prefiltration during x-ray release. This defect may result in a higher-than-intended radiation dose-rate for patients.

How to tell if you have it

Brand: Siemens
Product: ARTIS One Angiographic X-Ray System
Model Number: 10848600
Units affected: 1,140

The hazard

A potential issue with ARTIS One systems was identified where the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If this occurs, the applied radiation dose-rate may be higher than intended by the user.

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 an AGFA DR 800 X-Ray System recall for exceeding air kerma limits (Nov. 18, 2025) and RayStation/RayPlan Software recalls for radiation dose calculation risks (Nov. 28, 2025).

How to tell if you have this one

Check for the ARTIS One Angiographic X:Ray System with model number 10848600. This product was sold by Siemens Medical Solutions USA, Inc.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Siemens
Reach out to Siemens Medical Solutions USA, Inc for guidance on whether your system is affected and next steps.

How this recall unfolded

Recall timeline

FDA published this recall 34 days after the firm started it.

Jan 2, 2025Firm started the recall
Jan 28, 2025FDA classified it Class II
Feb 5, 2025Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/53158-siemens-artis-one-x-ray-system-recall-incorrect-radiation-dose">Siemens ARTIS One X-Ray System Recall: Incorrect Radiation Dose Risk (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-0922-2025 (January 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0922-2025 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.