BEUDAMED
    FDA Enforcement Class II Terminated

    Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

    Recall: Z-0860-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0860-2016
    Event ID
    73138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    January 20, 2016
    Classification Date
    February 23, 2016
    Termination Date
    February 7, 2017
    Address
    1069 State Road 46 E, N/A, Batesville, IN, 47006-7520, United States

    Description

    Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

    Reason

    The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.

    Code Info

    Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range: L341RW9151 through P070RW0812

    Distribution

    Worldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico. **Consumer Recommended Depth - Consumers/User**

    Quantity

    216