NDDd Medical Technologies, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0597-2020)
See the recall detail below. You can also see other recalls from the same firm in 2019.
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Class II
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.
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
The products were distributed to the following US states: KY, MO, NY, OH, PA
Voluntary: Firm initiated