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Recall Observatory FDA recall evidence

Device product

EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

Z-0597-2020

August 15, 2017

Class II

Product summary

Firm
NDDd Medical Technologies, Inc.
Event
Event 83992
Status
Terminated
Classification
Class II
Quantity
37 total devices
Official record key
device-enforcement:Z-0597-2020

Official wording

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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.