BEUDAMED
    FDA Recall Terminated

    Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. General-purpose radiographic system component used to suspend the system's image monitor.

    Recall: Z-0200-2009 · Initiated March 9, 2007

    Recall

    Recall Number
    Z-0200-2009
    Event Number
    49581
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    IZO
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    March 9, 2007
    Posted
    October 27, 2008
    Terminated
    August 24, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. General-purpose radiographic system component used to suspend the system's image monitor.

    Reason

    GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that suspensions manufactured after March 8, 1995 did not have the required thread locking agent applied to the setscrew, allowing the setscrew to back out over time, which can lead to the monitor dropping

    Action

    Consignees were sent a GE Healthcare "Product Safety Notification" letter dated September 13, 2007. The letter was addressed to Hospital Administrators/Managers of Radiology/Radiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information. The letter recommends that customers move the monitor suspension to an open area in the room where viewing is still possible and make sure to minimize the movement of the monitor until a Qualified GE Healthcare Field Engineer has inspected the suspension. The letter also states that a Qualified GE Healthcare Field Engineer will schedule a field visit to inspect the monitor suspension. Customers should contact their sales or service rep is they have any questions.

    Distribution

    Worldwide Distribution --- USA including states of AZ, CA, FL, GA, IA, MD, MO, NC, NY, OH, OK, TN, TX,WI, and LA, and country of Slovak Republic.

    Quantity

    21