FDA-Device2018-11-21Class II
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Invivo Corporation
Hazard
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
Sold states
Distributed to the Netherlands
Affected count
76 units
Manufactured in
12151 Research Pkwy Ste 200, Orlando, FL, United States
Products
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0462-2019Don't want to check this manually?
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