BEUDAMED
    FDA Enforcement Class II Terminated

    Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765

    Recall: Z-2962-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2962-2018
    Event ID
    80727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bayer Medical Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2018
    Initiation Date
    June 28, 2018
    Classification Date
    August 31, 2018
    Termination Date
    November 26, 2018
    Address
    1 Bayer Dr, N/A, Indianola, PA, 15051-9702, United States

    Description

    Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765

    Reason

    The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.

    Code Info

    Serial Numbers: 917/21956, 516/21035, 817/21916, 817/21910

    Distribution

    The devices were distributed to the following US states: OH, TX, and WV.

    Quantity

    4