BEUDAMED
    FDA Recall Terminated

    HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.

    Recall: Z-0007-2011 · Initiated May 1, 2009

    Recall

    Recall Number
    Z-0007-2011
    Event Number
    54154
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 1, 2009
    Posted
    December 17, 2010
    Terminated
    May 16, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.

    Reason

    It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.

    Action

    GE Healthcare will bring customer systems into compliance with 21 CFR by having a GE Healthcare field service representative, who will perform a field corrective action, visit each customer site. This will be carried out via a Field Modification Instruction planned to be released in October 2009 and planned to be completed by February 2010. Additionally, all forward production operator consoles are manufactured so as to comply with 21 CFR and to include a manufacturing check for appropriate labeling.

    Distribution

    Worldwide Distribution -- USA, including states of ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, and WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia.

    Quantity

    45 units (13 Nationwide)