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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

MIM Software Recalled for Incorrect Radiation Measurement Calculations

Agency Publication Date: March 4, 2025
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Summary

MIM Software Inc. has recalled 352 units of its radiological image processing software, including MIM Anyware 1.1 and MIM software versions 7.2.0 through 7.2.6. The software may calculate incorrect, elevated radiation measurement values when merging two images that have different fields of view. No injuries or incidents have been reported, but the error can misrepresent data used for patient treatment planning. Consumers should stop using the software for these specific image fusion tasks and contact the manufacturer for a correction.

Risk

Incorrect radiation measurements could lead to inaccurate medical assessments or errors in treatment planning for patients. The software specifically displays elevated 'Maximum Standardized Uptake Values' (SUV), which measures how much radioactive tracer is absorbed by body tissues.

What You Should Do

  1. This recall affects MIM Software radiological image processing systems, specifically software versions 7.2.0, 7.2.1, 7.2.2, 7.2.3, 7.2.4, 7.2.5, 7.2.6, and MIM Anyware version 1.1.
  2. Identify if you are using an affected version by checking the 'About' section within the software application or reviewing your system's installation documentation. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

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: MIM Anyware
Variants: Version 1.1
UDI:
Not Applicable

System, Image Processing, Radiological

Product: MIM Software
Variants: Version 7.2.0, Version 7.2.1, Version 7.2.2, Version 7.2.3, Version 7.2.4, Version 7.2.5, Version 7.2.6
UDI:
00850009343192

System, Image Processing, Radiological; Recall #: Z-1267-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96314
Status: Active
Manufacturer: MIM Software Inc
Sold By: Direct from manufacturer
Manufactured In: United States
Units Affected: 352 units
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.