BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0596-2020 · Initiated August 15, 2017

    Recall

    Recall Number
    Z-0596-2020
    Event Number
    83992
    Firm
    NDDd Medical Technologies, Inc.
    FEI Number
    3002918917
    Product Code
    BTY
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    August 15, 2017
    Terminated
    May 5, 2020
    Address
    2 Dundee Park Dr, Andover, MA, 01810-3735

    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.

    Action

    Customers were contacted via email or telephone between 8/1/17 and 4/13/19. The emails including the following information: We wanted to inform you that we are planning a preventive repair for some of our recently delivered EasyOne Pro/LAB V05 devices. The repair is related to an internal shielding component against electromagnetic disturbances. In some rare cases this could potentially lead to DLCO or MBW that cannot be performed. Although the probability of occurrence is very low, we want to absolutely ensure the quality of our devices and therefore we would like to make arrangements to update the shielding of this affected device. It is important to note, that all costs regarding the necessary repair will be covered by ndd, including all potential expenses. I would like to discuss handling of the repair and covering of the cost at the time of the repair. Of course, we already ensured that all newly delivered devices are not affected by the shielding issue. You can therefore order devices normally, there is no special action required. We are very sorry for the inconvenience this might be causing you as well as our shared customers and are committed to help as much as possible to ensure a smooth exchange of the affected component. Can you please contact me so we can make arrangements?

    Distribution

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

    Quantity

    37 total devices