BEUDAMED
    FDA Recall Terminated

    FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

    Recall: Z-0058-04 · Initiated August 27, 2003

    Recall

    Recall Number
    Z-0058-04
    Event Number
    27202
    Firm
    Hill-Rom Manufacturing, Inc.
    FEI Number
    1045510
    Product Code
    IOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 27, 2003
    Posted
    October 24, 2003
    Terminated
    July 1, 2004
    Address
    4349 Corporate Road, Charleston, SC, 29405

    Description

    FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

    Reason

    Reports of patient entrapment between mattress and side-rails.

    Action

    Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.

    Distribution

    Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.

    Quantity

    515 units