BEUDAMED
    FDA Recall Terminated

    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    Recall: Z-0373-2007 · Initiated January 12, 2007

    Recall

    Recall Number
    Z-0373-2007
    Event Number
    37121
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2007
    Posted
    January 25, 2007
    Terminated
    February 3, 2010
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    Reason

    The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.

    Action

    GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.

    Distribution

    Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom.

    Quantity

    198 units