BEUDAMED
    FDA Recall Open, Classified

    IntelePACS - InteleConnect / TechPortal

    Recall: Z-0723-2026 · Initiated October 17, 2025

    Recall

    Recall Number
    Z-0723-2026
    Event Number
    97868
    Firm
    INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada
    FEI Number
    3003768392
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    October 17, 2025
    Posted
    November 26, 2025

    Description

    IntelePACS - InteleConnect / TechPortal

    Reason

    Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

    Action

    On 10/17/2025, correction notices were emailed to customers who were asked to do the following: 1. Schedule Feature Release Upgrade (FRU) update immediately with the firm's Customer Success Manager (CSM). 2. Interim Mitigation: Until the update is applied, please advise all staff to verify the 'Relevant Clinical Info' field after any Case Editor modifications and consider temporarily documenting critical clinical information in alternative fields as backup. 3. complete and return the Acknowledgement Form via email to [email protected]. For more information or to ask any questions about the notification contact the firm's regulatory affairs department at [email protected]

    Distribution

    US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.

    Quantity

    19