BEUDAMED
    FDA Recall Terminated

    TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

    Recall: Z-0949-2013 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-0949-2013
    Event Number
    64580
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    IOQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 26, 2013
    Posted
    March 14, 2013
    Terminated
    April 16, 2014
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520

    Description

    TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

    Reason

    In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,

    Action

    Hill-Rom sent an Urgent Field Safey Notice letter dated February 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter advised customers to follow steps provided until the updated software is available. Customers were requested to forward a copy of this letter to any other facility personnel you deem appropriate. Questions should be directed to Hill-Rom Technical Support at 800-445-3720

    Distribution

    USA Nationwide Distribution including the state of Canada

    Quantity

    309