BEUDAMED
    FDA Recall Open, Classified

    Change Healthcare Radiology Solutions software version 14.2.2

    Recall: Z-0030-2026 · Initiated August 13, 2025

    Recall

    Recall Number
    Z-0030-2026
    Event Number
    97545
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    FEI Number
    3003757840
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    August 13, 2025
    Posted
    October 2, 2025
    Address
    10711 Cambie Rd, Suite 130, Richmond Canada

    Description

    Change Healthcare Radiology Solutions software version 14.2.2

    Reason

    Due to software issue, radiology reports may not be fully displayed when viewing.

    Action

    On August 13, 2025, Change Healthcare Canada Company issued a Urgent Medical Device Recall notification to affected consignees via Email. Chang Healthcare asked consignees to take the following actions: 1. Generate an audit report to list all studies accessed since CHRS 14.2.2 client was first installed. 2. Re-evaluate the identified cases and take any necessary follow-up measures to confirm that each patient s diagnosis and management remain appropriate. 4. This notice must be distributed to all personnel within your organization who need to be aware 5. To ensure effectiveness of any required corrective actions, please maintain awareness of this RECALL until the issue has been fully resolved. 6. Please notify our Customer Support department at: 1-800-663-2533 that you have read and understood the recall notice and schedule your product update to be installed on your system.

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.

    Quantity

    12 programs