NDDd Medical Technologies, Inc. recalls EasyOne Pro Respiratory Analysis System Pulmonary Function T
Recalled Product
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Hazard / Issue
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.
Issued by
FDA
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