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

Recall date

August 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0596-2020

FDA classification

Class II

Brand / firm

NDDd Medical Technologies, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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