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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

ARTIS One Angiographic X-Ray System Recalled for Radiation Dose Risk

Agency Publication Date: January 29, 2025
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Summary

Siemens Medical Solutions USA, Inc. has recalled 1,140 units of the ARTIS One Angiographic X-Ray System (Model Number 10848600). The recall was issued because a software issue can cause the system to use the wrong copper filter during the first X-ray taken after a patient is registered. This defect can lead to a radiation dose-rate that is higher than what the medical professional intended for the patient.

Risk

Patients may receive unintended levels of radiation during imaging procedures, which can increase the risk of radiation-related health complications. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall involves the ARTIS One Angiographic X-Ray System, specifically Model Number 10848600.
  2. Stop using the recalled device immediately.
  3. Contact the manufacturer, Siemens Medical Solutions USA, Inc., or your authorized distributor to arrange for a return, replacement, or corrective service.
  4. If you were notified of this recall via a letter from Siemens on or after January 2, 2025, follow the specific technical instructions provided in that correspondence.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ARTIS One Angiographic X-Ray System
Model / REF:
10848600

Recall Number: Z-0922-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96088
Status: Active
Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC
Sold By: Authorized medical device distributors; Siemens Healthineers sales
Manufactured In: Germany
Units Affected: 1140
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.