BEUDAMED
    FDA Recall Completed

    VariCam

    Recall: Z-0704-2019 · Initiated October 30, 2017

    Recall

    Recall Number
    Z-0704-2019
    Event Number
    81736
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Completed
    Root Cause
    Other
    Initiated
    October 30, 2017
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    VariCam

    Reason

    A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.

    Action

    The firm initiated the medical device correction by letter on 10/0/2017. The letter instructed the consignee to ensure the collimator locking handles are in the locked position at all times. GE Healthcare will inspect and if necessary correct all affected products.

    Distribution

    Worldwide

    Quantity

    64 units