Invivo Corporation recalls Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Recall date

August 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3192-2018

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

Distribution in the Netherlands

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388