BEUDAMED
    FDA Enforcement Class II Terminated

    EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

    Recall: Z-0597-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0597-2020
    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 LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

    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: 650074 650085 650075 650086 650076 650087 650079 650088 650080 650089 650081 650090 650082 650091 650083 650092 650094 650095 650096 650098 650099 650100 650104 650055 650058 650062 650066 650067 650069 650070 650073

    Distribution

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

    Quantity

    37 total devices