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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

Intelerad InteleShare Software Recalled for Inaccurate Measurement Tool Bug

Agency Publication Date: December 18, 2025
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Summary

Approximately 924 units of Intelerad InteleShare software (versions 3.24.3 through 3.25.2) with the ProViewer component are being recalled by DICOM Grid, Inc. The software contains a defect that occurs when users view images using the multiplanar reconstruction (3D viewing) feature and apply manual rotation. This bug causes the software's length measurement tool to display incorrect values, which was first distributed on August 28, 2024.

Risk

The software bug can lead to inaccurate measurements of anatomical structures, which may cause a clinician to misdiagnose a condition or provide inappropriate follow-up care. No specific injuries or incidents have been reported, but the error directly compromises diagnostic accuracy.

What You Should Do

  1. This recall affects Intelerad InteleShare software (versions 3.24.3 through 3.25.2) equipped with the ProViewer component and UDI-DI B228INTELESHARE0.
  2. Identify if your software installation is within the affected version range (3.24.3 to 3.25.2) by checking the 'About' or system information section of the application.
  3. Be aware that the measurement error only occurs when all of the following conditions are met: you are viewing images in the InteleShare viewer, multiplanar reconstruction is applied, and manual rotation is used.
  4. Stop using the recalled software for diagnostic measurements that involve manual rotation in reconstructed views.
  5. Contact DICOM Grid, Inc. or your authorized software distributor to arrange for a software correction, technical update, or further instructions.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical 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: Intelerad InteleShare software, with ProViewer component
Variants: Software versions 3.24.3 - 3.25.2
UDI:
B228INTELESHARE0
Date Ranges: First Distribution: 2024-08-28

Recall Number: Z-0941-2026. Bug affects length measurement tool values during manual rotation in multiplanar reconstruction.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97993
Status: Active
Manufacturer: DICOM Grid, Inc.
Sold By: Authorized Distributors; Direct Sales
Manufactured In: United States
Units Affected: 924
Distributed To: Arizona, Texas, Georgia, Nevada, Missouri, Michigan, Illinois, Ohio, Connecticut, Oregon, Florida, New York, New Mexico, Minnesota, Pennsylvania, Alaska, North Dakota, New Jersey, Virginia, Washington, North Carolina, Tennessee, Wisconsin, California, South Dakota, Colorado, Massachusetts, West Virginia, Kansas, Maryland, Vermont, Iowa, Rhode Island, Alabama, Idaho, Louisiana, Puerto Rico, New Hampshire, Indiana, Oklahoma, Utah, Nebraska, South Carolina, Arkansas, Delaware

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.