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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

AGFA DR 800 X-Ray Systems Recalled for Excessive Radiation Exposure Risk

Agency Publication Date: December 22, 2025
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Summary

AGFA Healthcare Corp. has recalled 35 units of the AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic. The recall was issued because the system can exceed the maximum allowed radiation rate of 88mGy/min during pulsed fluoroscopy exams. This issue occurs when the framerate is increased on the NX workstation while the Automatic Brightness System is turned off, which may lead to unintentional overexposure.

Risk

Patients may be exposed to higher-than-permitted levels of radiation during diagnostic procedures. Excessive radiation exposure can increase the risk of radiation-induced injuries and potential long-term health complications.

What You Should Do

  1. This recall affects the AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic, also known as the DR 800. These systems may be used in hospitals or clinical imaging centers.
  2. Stop using the recalled device. Contact AGFA Healthcare Corp. or your equipment distributor to arrange for a necessary correction, software update, or repair to address the radiation rate settings.
  3. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this device recall.

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: AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic
Model / REF:
DR 800

Affected when the framerate is increased on the NX workstation while the Automatic Brightness System (ABS) is not enabled.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98101
Status: Active
Manufacturer: AGFA Healthcare Corp.
Sold By: Hospital suppliers; Medical device distributors
Manufactured In: United States
Units Affected: 35
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.