BEUDAMED
    FDA Recall Terminated

    Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

    Recall: Z-0870-2009 · Initiated December 12, 2008

    Recall

    Recall Number
    Z-0870-2009
    Event Number
    50540
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 12, 2008
    Posted
    January 12, 2009
    Terminated
    May 18, 2010
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

    Reason

    Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.

    Action

    GE Healthcare Integrated IT Solutions notified their Centricity Enterprise Web software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomalies resulting in patient safety issues involving a forced log off during an open session while using the Centricity Enterprise Web and measurements displayed in Centricity Enterprise Web will use the calibration provided by the original scanning modality. Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 414-918-4653. For further information, please contact GE Customer Care Center by telephone at 800-437-1171.

    Distribution

    Worldwide Distribution including USA and countries of Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway, Portugal, Reunion, Russia, Saudi Arabia, Slovenia, Singapore, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezuela.

    Quantity

    742 units