BEUDAMED
    FDA Enforcement Class II Terminated

    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

    Recall: Z-0596-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0596-2020
    Event ID
    83992
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NDDd Medical Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 11, 2019
    Initiation Date
    August 15, 2017
    Classification Date
    December 3, 2019
    Termination Date
    May 5, 2020
    Address
    2 Dundee Park Dr, Andover, MA, 01810-3735, United States

    Description

    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

    Reason

    The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.

    Code Info

    Serial Numbers: 550066 550067 550068 550069 550071 550072

    Distribution

    The products were distributed to the following US states: KY, MO, NY, OH, PA

    Quantity

    37 total devices