FDA recall Z-0597-2020

Product

EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

Reason for recall

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.

Distribution

The products were distributed to the following US states: KY, MO, NY, OH, PA

Key facts

Status

Terminated

Initiation date

2017-08-15

Report date

2019-12-11

Termination date

2020-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2020