BEUDAMED
    FDA Recall Terminated

    GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image intensifier. GE Healthcare

    Recall: Z-1485-06 · Initiated November 1, 2006

    Recall

    Recall Number
    Z-1485-06
    Event Number
    36409
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2006
    Posted
    September 30, 2006
    Terminated
    February 24, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image intensifier. GE Healthcare

    Reason

    Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)

    Action

    Correction to devices is being implemented through GEHC Field Modification Instructions.

    Distribution

    within US: CO, IL, LA, MA, MI, NC, PA, SC,TN, VA. OUS to include: Austrailia, Belgium, Burkina Faso, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Italy, Republic of Korea, Lebanon, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Taiwan, Republic of China, United Kingdom

    Quantity

    83