BEUDAMED
    FDA Recall Terminated

    PR1000 Pivot Rehab Bed AC powered adjustable bed.

    Recall: Z-3183-2018 · Initiated July 25, 2018

    Recall

    Recall Number
    Z-3183-2018
    Event Number
    80832
    Firm
    Med-Mizer, Inc.
    FEI Number
    3004976058
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 25, 2018
    Terminated
    October 11, 2019
    Address
    80 Commerce Dr, Batesville, IN, 47006-6700

    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

    Action

    Customers were contacted via telephone on 7/25/18 to notify them of the issue and to make them aware of the correction. Customers were then mailed a notification letter along with necessary parts.

    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