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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

PTW-FREIBURG: VERIQA Software Recalled for Incorrect Radiation Dose Calculations

Agency Publication Date: February 22, 2024
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Summary

PTW-FREIBURG is recalling its VERIQA software (versions 2.0 and 2.1) because the system may incorrectly calculate the 'Gamma Passing Rate' when certain dose thresholds are excluded. This defect can lead to an overestimation of the passing rate, potentially resulting in false-positive evaluations for medical treatment plans. Approximately 65 units are affected worldwide, including one unit distributed in Georgia. Consumers should contact their healthcare provider or the manufacturer immediately for guidance on software updates or alternative verification methods.

Risk

The software may report that a radiation treatment plan is accurate when it actually contains errors. This overestimation could lead to patients receiving incorrect radiation doses during oncology treatments, potentially impacting the safety and effectiveness of the therapy.

What You Should Do

  1. Identify if you are using VERIQA software version 2.0 or 2.1 by checking the 'About' section or system information within the application.
  2. Be aware that the issue occurs specifically when the 'Suppress gamma calculation' feature is used to exclude voxels below a certain dose threshold.
  3. Verify the accuracy of any current treatment evaluations that utilized these specific software versions and settings.
  4. Contact PTW-FREIBURG or your medical device coordinator to discuss corrective software patches or instructions provided in the firm's email notification sent on February 8, 2024.
  5. Contact your healthcare provider or the manufacturer directly for further instructions regarding the software and potential corrective actions.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Software VERIQA (S070031), version 2.0 and 2.1
Model / REF:
S070031

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93988
Status: Active
Manufacturer: PTW-FREIBURG
Sold By: Specialty medical distributors
Manufactured In: Germany
Units Affected: 1 US; 65 worldwide
Distributed To: Georgia

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.

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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.