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NDDd Medical Technologies, Inc. recalls EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Recalled December 11, 2019 · FDA recall Z-0597-2020 · NDDd Medical Technologies
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. · FDA Class II
Units
37 total devices
Sold at
The products were distributed to the following US states: KY, MO, NY, OH, PA
Description
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.
Product
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Manufacturer(s)
NDDd Medical Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →