IntelePACS Software Recalled Due to Incorrect Diagnosis Risk

Agency Publication Date: February 21, 2025

Summary

Intelerad Medical Systems Incorporated has recalled 88 units of its IntelePACS (Image Fusion Module) InteleViewer software, specifically versions 5-6-1-P23 and later. The software contains a bug that causes the Standard Uptake Value (SUV) to be calculated incorrectly for PET/CT scans acquired on the specific days when Daylight Savings Time (DST) transitions occur. While no injuries have been reported, these incorrect calculations could lead to a wrong medical diagnosis for patients scanned on those dates.

Risk

A software error calculates incorrect medical data during scans performed on Daylight Savings Time transition dates. This inaccuracy poses a risk of incorrect diagnoses, which could lead to improper patient treatment or missed medical conditions.

What You Should Do

This recall affects IntelePACS (Image Fusion Module) - InteleViewer software, versions 5-6-1-P23 and later, identified by UDI-DI B228INTELEPACS0.
Check the software version information within your InteleViewer application to confirm if you are using version 5-6-1-P23 or any subsequent version.
Stop using the recalled software for PET/CT studies acquired on Daylight Savings Time transition dates, as the calculations for these specific dates are unreliable.
Contact Intelerad Medical Systems Incorporated or your software distributor to arrange for a software correction, update, or to receive further technical instructions regarding this issue.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IntelePACS (Image Fusion Module) - InteleViewer

Variants: Device Versions: 5-6-1-P23 and later

UDI:

B228INTELEPACS0

Bug affects PET/CT studies acquired only on Daylight Savings Time (DST) transition dates.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96270

Status: Active

Manufacturer: INTELERAD MEDICAL SYSTEMS INCORPORATED

Sold By: Hospitals; Imaging Centers; Diagnostic Clinics

Manufactured In: Canada

Units Affected: 88

Distributed To: Arizona, North Carolina, Michigan, Florida, New Hampshire, Wyoming, California, South Carolina, Alabama, Arkansas, Indiana, Maryland, Colorado, Tennessee, Illinois, New Jersey, Ohio, Minnesota, West Virginia, Kentucky, Nebraska, Virginia, Washington, Georgia, Wisconsin

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 · 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.

Summary

What You Should Do

This recall affects IntelePACS (Image Fusion Module) - InteleViewer software, versions 5-6-1-P23 and later, identified by UDI-DI B228INTELEPACS0.

Check the software version information within your InteleViewer application to confirm if you are using version 5-6-1-P23 or any subsequent version.

Stop using the recalled software for PET/CT studies acquired on Daylight Savings Time transition dates, as the calculations for these specific dates are unreliable.

Contact Intelerad Medical Systems Incorporated or your software distributor to arrange for a software correction, update, or to receive further technical instructions regarding this issue.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.