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NDDd Medical Technologies Recalls
2 recalls on record · December 11, 2019 to December 11, 2019 · Medical Devices
December 11, 2019Medical DevicesFDA
NDDd Medical Technologies, Inc. recalls EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Hazard: 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.
December 11, 2019Medical DevicesFDA
NDDd Medical Technologies, Inc. recalls EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Hazard: 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.