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

Recalled November 21, 2018 · FDA recall Z-0462-2019 · Invivo

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 · FDA Class II
Units
76 units
Sold at
Distributed to the Netherlands

Description

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

Product
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Manufacturer(s)
Invivo Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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