BEUDAMED
    FDA Recall Terminated

    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

    Recall: Z-0180-2015 · Initiated October 1, 2014

    Recall

    Recall Number
    Z-0180-2015
    Event Number
    69324
    Firm
    Nellcor Puritan Bennett Inc. (dba Covidien LP)
    FEI Number
    2936999
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 1, 2014
    Posted
    December 9, 2014
    Terminated
    July 1, 2016
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

    Reason

    Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.

    Action

    Update: Consignees were notified on 12/11/14 of strategy change after Covidien sent an Urgent Field Safety Corrective Action notification with instructions dated September 2014 via traceable courier to affected consignees. The letter identifed the affected product, problem and actions to be taken. Consignees were instructed to complete the attached verification form and fax it to the Covidien RMS contact indicated on the form. If you need further assistance, contact the Technical Support Department @ 1-800-255-6774, option 4, then option 1.

    Distribution

    Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.

    Quantity

    324 units