BEUDAMED
    FDA Enforcement Class II Terminated

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    Recall: Z-0409-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0409-2013
    Event ID
    62805
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KCI USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    June 27, 2012
    Classification Date
    November 20, 2012
    Termination Date
    April 22, 2013
    Address
    4958 Stout Dr, N/A, San Antonio, TX, 78219-4334, United States

    Description

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    Reason

    The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.

    Code Info

    Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.

    Distribution

    Nationwide Distribution including AL, CA, CO, OK and GA.

    Quantity

    282 units