BEUDAMED
    FDA Recall Terminated

    Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.

    Recall: Z-1850-2014 · Initiated April 4, 2014

    Recall

    Recall Number
    Z-1850-2014
    Event Number
    68128
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 4, 2014
    Posted
    June 23, 2014
    Terminated
    October 15, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.

    Reason

    Potential for the welded seam in affected monitor spring arms to crack and/or break.

    Action

    On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.

    Distribution

    Distribution to US (states: MA, NY, OH, PA & TX) and Canada.

    Quantity

    68 units