BEUDAMED
    FDA Recall Terminated

    GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

    Recall: Z-0985-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-0985-2015
    Event Number
    70074
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 19, 2014
    Posted
    January 15, 2015
    Terminated
    April 29, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

    Reason

    Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.

    Action

    Consignees were sent on 12/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC # 25457 dated December 19, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US phone 800-437-1171, Japan 0120-055-919, other countries contact your local GE Healthcare Service Representative).

    Distribution

    US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.

    Quantity

    13 (7 US, 6 OUS)