Home / Recalls / NDDd Medical Technologies, Inc. / Z-0596-2020

Z-0596-2020 Class II Terminated

Recalled by NDDd Medical Technologies, Inc. — Andover, MA

Recall Details

Product Type: Devices
Report Date: December 11, 2019
Initiation Date: August 15, 2017
Termination Date: May 5, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 37 total devices

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

Serial Numbers: 550066 550067 550068 550069 550071 550072