Lower risk Medical device recall · FDA · Published May 15, 2025

Siemens X-Ray System May Report High Dose Incorrectly

Siemens Medical Solutions recalls interventional fluoroscopic x-ray systems that may incorrectly report high radiation doses due to rare sensor-software communication failure.

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

🇺🇸 FDA recall #Z-2020-2025Medical device Siemens ›

Lower-risk recall

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens is recalling interventional fluoroscopic x-ray systems that could incorrectly report high radiation doses in rare cases. This might lead to unnecessary radiation exposure during procedures if the system's dose readings are not trusted. Read more at govinfonow.com/recall/52265-siemens-x-ray-system-may-report-high-dose-incorrectly.

Source Summary by GovInfoNow · govinfonow.com/recall/52265-siemens-x-ray-system-may-report-high-dose-incorrectly · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2020-2025

Cite this page

“Siemens X-Ray System May Report High Dose Incorrectly.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52265-siemens-x-ray-system-may-report-high-dose-incorrectly. Based on FDA recall #Z-2020-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2020-2025%22&limit=1).

The FDA announced on May 15, 2025, that Siemens Medical Solutions USA, Inc. is recalling its interventional fluoroscopic x-ray systems due to a potential software failure that may incorrectly report high radiation doses. The agency issued the Class II recall under number Z-2020-2025.

How to tell if you have it

Siemens
interventional fluoroscopic x-ray system
UPC: 4056869063317

The hazard

The recall addresses a rare failure in communication between the dose sensor and the corresponding software. This malfunction may cause the system to incorrectly report an application of a high dose, according to the FDA.

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 the AGFA DR 800 X-Ray System Recall (Nov. 18, 2025) and RayStation/RayPlan Software Recalls (Nov. 28, 2025).

How to tell if you have this one

This recall applies to Siemens interventional fluor: 4056869063317. The product is used in medical settings for procedures like angiography and vascular interventions.

Brand
Siemens
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide.

Recall number	Product, codes & lots	Quantity
Z-2019-2025	ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.; 4056869046877	—
Z-2020-2025	interventional fluoroscopic x-ray system; 4056869063317	—
Z-2021-2025	interventional fluoroscopic x-ray system; 4056869295923	—
Z-2022-2025	interventional fluoroscopic x-ray system; 4056869149325	—

Based on the official FDA remedy

What to do — step by step

Check System Model
Look for the model number 4056869063317 on the system's label or documentation.

How this recall unfolded

Recall timeline

FDA published this recall 55 days after the firm started it.

May 15, 2025Firm started the recall
Jun 27, 2025FDA classified it Class II
Jul 9, 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/52265-siemens-x-ray-system-may-report-high-dose-incorrectly">Siemens X-Ray System May Report High Dose Incorrectly (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-2020-2025 (May 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2020-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.