BEUDAMED
    FDA Recall Open, Classified

    Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

    Recall: Z-0237-2024 · Initiated October 12, 2023

    Recall

    Recall Number
    Z-0237-2024
    Event Number
    93259
    Firm
    CHANGE HEALTHCARE CANADA COMPANY
    FEI Number
    3003757840
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 12, 2023
    Posted
    November 6, 2023
    Address
    10711 Cambie Rd, Suite 130, Richmond Canada

    Description

    Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

    Reason

    Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

    Action

    Field Safety Notice was distributed to all consignees on10/12/2023 by email. The notice explained the issue, potential risk to the patient, and directed users to to check the CHRS Exception Tracker on a regular basis, as failed updates will be listed with details on the failure. Recommended actions to take on potentially affected data: Impacted data can be identified by using the CHRS Exception Tracker. Customers are advised to review records of recent updates from CHRS to external systems and manually update any changes to study records that may have been missed. Change Healthcare will install a software update.

    Distribution

    US, Canada, Ireland, Saudi Arabia, France, UK

    Quantity

    282 units