BEUDAMED
    FDA Recall Terminated

    Centricity PACS Software Version 7.0 SP0.0.4.7

    Recall: Z-1466-2022 · Initiated June 14, 2022

    Recall

    Recall Number
    Z-1466-2022
    Event Number
    90525
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 14, 2022
    Terminated
    January 16, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Centricity PACS Software Version 7.0 SP0.0.4.7

    Reason

    The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

    Action

    An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.

    Quantity

    47 installations