BEUDAMED
    FDA Enforcement Class II Terminated

    OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

    Recall: Z-2267-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2267-2015
    Event ID
    71583
    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
    August 5, 2015
    Initiation Date
    June 29, 2015
    Classification Date
    July 27, 2015
    Termination Date
    November 3, 2017
    Address
    6135 Gunbarrel Ave, N/A, Boulder, CO, 80301-3214, United States

    Description

    OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

    Reason

    Potential missing segments on the display that can result in misinterpretation of data.

    Code Info

    All Lots of Product Code N650, N65, N65-1, N65P, N65P-1

    Distribution

    Worldwide Distribution - US Nationwide including Canada.

    Quantity

    211,426 units