BEUDAMED
    FDA Recall Terminated

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    Recall: Z-0438-2019 · Initiated October 8, 2018

    Recall

    Recall Number
    Z-0438-2019
    Event Number
    81211
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 8, 2018
    Terminated
    April 28, 2020
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    Reason

    The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.

    Action

    Medical Device Correction notification letters were distributed to customers on 10/8/18.

    Distribution

    The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries: Canada.

    Quantity

    20,030 total