BEUDAMED
    FDA Enforcement Class II 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 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1850-2014
    Event ID
    68128
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    April 4, 2014
    Classification Date
    June 23, 2014
    Termination Date
    October 15, 2014
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    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.

    Code Info

    Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A. Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.

    Distribution

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

    Quantity

    68 units