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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

IntelePACS Software Recalled for Bug Causing Clinical Data Loss

Agency Publication Date: November 26, 2025
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Summary

Intelerad Medical Systems has recalled 19 units of its IntelePACS - InteleConnect / TechPortal software due to a bug in the Case Editor. This software bug can cause clinical information to be deleted or lost when modifications are made through the Technologist Portal or Referring Physician Portal. The loss of relevant clinical data can lead to incorrect medical decisions and impact patient care. This recall affects specific software versions distributed between June and September 2025.

Risk

A bug in the software's Relevant Clinical Info field can cause critical patient data to be lost during study modifications. If clinical information is missing, healthcare providers may make decisions based on incomplete data, potentially leading to misdiagnosis or delayed treatment.

What You Should Do

  1. The recalled product is Intelerad IntelePACS - InteleConnect / TechPortal software, specifically versions PACS-5-6-1-R64 through R68, PACS-5-7-1-R42 through R47, PACS-5-8-1-R20 through R23, and PACS-5-9-1-R1 through R3.
  2. Identify the software version currently in use by checking the system settings or about menu in either the Technologist Portal or Referring Physician Portal. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled software for modifying clinical studies in the Case Editor if you suspect data loss is occurring.
  4. Contact Intelerad Medical Systems or your local IT administrator to arrange for a software patch, update, or correction to resolve the bug.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

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

Affected Products

Product: IntelePACS - InteleConnect / TechPortal
Model / REF:
PACS-5-6-1-R64 through R68
PACS-5-7-1-R42 through R47
PACS 5-8-1-R20 through R23
PACS-5-9-1-R1 through R3
UDI:
B228INTELEPACS0
Date Ranges: July 2, 2025 - September 10, 2025, June 26, 2025 - September 25, 2025, June 30, 2025 - September 9, 2025

Bug affects Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97868
Status: Active
Manufacturer: INTELERAD MEDICAL SYSTEMS INCORPORATED
Sold By: Hospital networks; Radiology clinics; Referring physicians
Manufactured In: Canada
Units Affected: 19
Distributed To: Arizona, Connecticut, Alabama, Illinois, Washington, Maryland, New Jersey, California, Tennessee, Indiana, Florida, North Carolina

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.