FDAAugust 15, 2017device
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
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UPCs
650074650085650075650086650076650087650079650088650080650089650081650090650082650091650083650092
Recall history
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