BEUDAMED
    FDA Recall Terminated

    ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. The ViewSonic 19" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products

    Recall: Z-0349-2011 · Initiated May 1, 2009

    Recall

    Recall Number
    Z-0349-2011
    Event Number
    51883
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 1, 2009
    Posted
    November 12, 2010
    Terminated
    July 25, 2011
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

    ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. The ViewSonic 19" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products

    Reason

    The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms.

    Action

    On May 1, 2009, Welch Allyn Protocol, Inc. sent out recall notification to their consignees in via UPS and US Postal Certified Mail. The letter describes the recalled product as 19" model VGM930M ViewSonic flat panel LCD display with serial numbers less than QC2082880001. For the Welch Allyn service contract consignees/customers, the firm's Field Service Engineer will replace the LCD monitor for the consignees. The consignees could contact Technical Support at 1-800-289-2501. For the Warranty/non-Warranty contract consignees/customers-For the Welch Allyn service contract consignees, Stericycle Return Management Services (RMS) will manage all recall and recovery initiatives. Consignees/customers can call Welch Allyn Customer Care at 1-800-535-6663 for any questions or concern about this recall.

    Distribution

    Worldwide distribution: USA including states of: AK, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VT, WI, and WV; and countries including: AUSTRALIA, CANADA, ESTONIA, GERMANY, ICELAND, IRELAND, ITALY, JORDAN, MALAYSIA, POLAND, and RUSSIA.

    Quantity

    637 units