BEUDAMED
    FDA Recall Open, Classified

    Proteus XR/a (SlOK : K993090)

    Recall: Z-2449-2019 · Initiated August 9, 2019

    Recall

    Recall Number
    Z-2449-2019
    Event Number
    83647
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 9, 2019
    Posted
    September 20, 2019
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Proteus XR/a (SlOK : K993090)

    Reason

    Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

    Action

    GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare representative will contact you to arrange for the correction . If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1- 800-437-1171or your local Service Representative.

    Distribution

    Worldwide - US Nationwide

    Quantity

    647 US; 167 OUS