FDA-Device2019-12-11Class II
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
NDDd Medical Technologies, Inc.
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.
Sold states
The products were distributed to the following US states: KY, MO, NY, OH, PA
Affected count
37 total devices
Manufactured in
2 Dundee Park Dr, Andover, MA, United States
Products
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2020Don't want to check this manually?
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