Invivo Corporation recalls Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

Recall date

September 24, 2018

Source

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

Recall number

Z-0462-2019

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

Distributed to the Netherlands

Why it was recalled

The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

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, Software version 1.6.0.0388