BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2962-2018 · Initiated June 28, 2018

    Recall

    Recall Number
    Z-2962-2018
    Event Number
    80727
    Firm
    Bayer Medical Care, Inc.
    FEI Number
    2520313
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 28, 2018
    Terminated
    November 26, 2018
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    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.

    Action

    On June 28, 2018, Urgent Medical Device Field Safety Corrective Action letters were distributed to customers. The letters informed the customers of the following: A Bayer Service Representative will be scheduling a service visit to replace the ceiling column assembly of your OCS system(s) at no cost to you.

    Distribution

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

    Quantity

    4