FDA recall Z-3192-2018

Product

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Reason for recall

Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.

Distribution

Distribution in the Netherlands

Key facts

Status

Terminated

Initiation date

2018-08-03

Report date

2018-09-26

Termination date

2021-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3192-2018