NDDd Medical Technologies, Inc.: EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

Recall number

Z-0596-2020

Recalling firm

NDDd Medical Technologies, Inc.

Product

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

Status

Terminated

Initiated

2017-08-15

Posted

not on file

Terminated

2020-05-05

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.

Root cause

Component change control

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?

Quantity

37 total devices

Distribution

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

Lot, serial or model codes

Serial Numbers: 550066 550067 550068 550069 550071 550072

510(k) numbers

["K161534"]

PMA numbers

not on file

Product code

BTY

Firm FEI

3002918917

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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