BEUDAMED
    FDA Enforcement Class II Terminated

    Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.

    Recall: Z-1864-2012 · Reported July 4, 2012

    Enforcement

    Recall Number
    Z-1864-2012
    Event ID
    62331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2012
    Initiation Date
    June 18, 2012
    Classification Date
    June 22, 2012
    Termination Date
    June 6, 2014
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520, United States

    Description

    Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.

    Reason

    During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.

    Code Info

    AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.

    Quantity

    7843 devices