BEUDAMED
    FDA Enforcement Class II Terminated

    PR1000 Pivot Rehab Bed AC powered adjustable bed.

    Recall: Z-3183-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3183-2018
    Event ID
    80832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med-Mizer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 26, 2018
    Initiation Date
    July 25, 2018
    Classification Date
    September 17, 2018
    Termination Date
    October 11, 2019
    Address
    80 Commerce Dr, N/A, Batesville, IN, 47006-6700, United States

    Description

    PR1000 Pivot Rehab Bed AC powered adjustable bed.

    Reason

    Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made

    Code Info

    ALL Pivot Rehab PR1000 Beds built between 12/01/2010 thru 12/22/2014 SN: PR 10001 build date 12/01/2010 thru PR 10255 build date 12/22/2014

    Distribution

    The products were distributed to the following US states: AR, AZ, FL, GA, IA, ID, IL, IN, KY, ME, MI, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. The products were distributed to the following foreign countries: Canada, China, and Denmark.

    Quantity

    230 units