BEUDAMED
    FDA Recall Terminated

    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required

    Recall: Z-0746-2017 · Initiated October 5, 2016

    Recall

    Recall Number
    Z-0746-2017
    Event Number
    75385
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 5, 2016
    Posted
    December 12, 2016
    Terminated
    April 14, 2017
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required

    Reason

    The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.

    Action

    Steris sent an Urgent Voluntary Field Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remind staff personnel that Harmony Insight Diagnostic Monitor Support Systems, including the affected Drager Pendula spring arms, are not designed or intended to be placed over hospital personnel or patients and should be moved with care. Customers with questions were instructed to call 440-392-7358 or Steris Customer Service at 1-800-548-4873. For questions regarding this recall call 440-392-7231.

    Distribution

    Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.

    Quantity

    63