Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0596-2020

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-0596-2020

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: 550066 550067 550068 550069 550071 550072

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.