Home / Recalls / NDDd Medical Technologies, Inc. / Z-0597-2020

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

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: 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