BEUDAMED
    FDA Recall Open, Classified

    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

    Recall: Z-1297-2021 · Initiated January 29, 2021

    Recall

    Recall Number
    Z-1297-2021
    Event Number
    87331
    Firm
    Stryker Communications
    FEI Number
    3002975342
    Product Code
    FQO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 29, 2021
    Address
    571 Silveron Blvd, Flower Mound, TX, 75028

    Description

    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

    Reason

    The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.

    Action

    An Urgent Customer Notification Letter was mailed (certified) to the affected consignees on 01/29/2021. Customers will be notified by letter and a Stryker Representative will visit each account for product inspection and replacement. If customers notice any issues prior to inspection, customers should discontinue use and call Technical Support immediately at (866) 841-5663.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY. The country of Canada.

    Quantity

    1,393 units