BEUDAMED
    FDA Enforcement Class II Terminated

    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.

    Recall: Z-1181-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1181-2016
    Event ID
    73096
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    January 15, 2016
    Classification Date
    March 16, 2016
    Termination Date
    July 11, 2017
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214, United States

    Description

    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.

    Reason

    Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.

    Code Info

    all versions of software.

    Distribution

    Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.

    Quantity

    1,864 units