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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

IBA myQA iON Software Recalled for Potential Incorrect Analysis Results

Agency Publication Date: April 30, 2025
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Summary

IBA Dosimetry GmbH is recalling 84 units of its myQA iON software (Article Number MQ10-000) because incorrect analysis results can occur under specific naming conditions. If a user creates two patient structures with the same name that differ only by a single special character, the software may fail to analyze the data correctly. No incidents or injuries have been reported to date regarding this software defect.

Risk

Incorrect software analysis results could lead to the use of inaccurate data during radiation therapy quality assurance. This poses a risk of improper patient treatment planning or dosage errors if the faulty analysis is not detected.

What You Should Do

  1. This recall affects the myQA iON radiation therapy quality assurance software, identified by Article Number MQ10-000 and UDI-DI EIBAMQ010000.
  2. Stop using the recalled software for clinical analysis until a correction has been implemented.
  3. Contact IBA Dosimetry GmbH or your authorized distributor to arrange for a software update or necessary correction to resolve the analysis issue.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.

Your Remedy Options

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

Affected Products

Product: myQA iON
Model / REF:
MQ10-000
UDI:
EIBAMQ010000

Recall Number: Z-1703-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96647
Status: Active
Manufacturer: IBA Dosimetry GmbH
Sold By: Direct Sales
Manufactured In: Germany
Units Affected: 84 units (9US, 75 OUS)
Distributed To: Alabama, Arkansas, Florida, Georgia, Kansas, Maryland, Oklahoma

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.