BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System.

    Recall: Z-0898-06 · Initiated March 6, 2006

    Recall

    Recall Number
    Z-0898-06
    Event Number
    34758
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 6, 2006
    Posted
    May 24, 2006
    Terminated
    February 24, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System.

    Reason

    Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

    Action

    GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.

    Distribution

    Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela

    Quantity

    291 (213 domestic and 78 OUS)