BEUDAMED
    FDA Enforcement Class II Terminated

    Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.

    Recall: Z-2737-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2737-2020
    Event ID
    85925
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2020
    Initiation Date
    June 30, 2020
    Classification Date
    July 30, 2020
    Termination Date
    October 20, 2022
    Address
    1069 State Road 46 E, N/A, Batesville, IN, 47006-7520, United States

    Description

    Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.

    Reason

    Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.

    Code Info

    Serial Numbers Affected: V133AW9885 through V142AW0261and manufactured between May 12, 2020 and May 21, 2020

    Distribution

    Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.

    Quantity

    257