BEUDAMED
    FDA Recall Terminated

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    Recall: Z-0269-05 · Initiated October 21, 2004

    Recall

    Recall Number
    Z-0269-05
    Event Number
    30278
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 21, 2004
    Posted
    February 24, 2005
    Terminated
    July 24, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    Reason

    The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling abruptly due to the filure of the upper shaft. No injuries were reported.

    Action

    Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.

    Quantity

    1150