BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1104-2008 · Initiated December 28, 2007

    Recall

    Recall Number
    Z-1104-2008
    Event Number
    46306
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 28, 2007
    Posted
    May 1, 2008
    Terminated
    May 17, 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

    Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.

    Action

    GE Healthcare IITS sent Product Safety Notification letters dated 12/28/07 to all customers who have the GE Centricity PACS RA1000 Workstation software versions 2.1.X, or 3.0.X, informing them of the potential patient safety issue involving the exam notes window, which may be used to provide various patient information including lab results. To mitigate this problem, the users were instructed not to use the following four special characters (greater than sign >, less than sign <, double quotation mark " and apostrophe ') in the exam notes field in order to prevent any adverse patient events. For example, if a lab result was entered as GFR <60, it should be typed as GFR less than 60. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the problem and the recommended actions 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 Distribution - USA, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, New Zealand, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    557 units