Company: Invivo Corporation
Date of Enforcement Report: 11/14/2018
Class II:
PRODUCT
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Recall Number: Z-0462-2019
REASON
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
RECALLING FIRM/MANUFACTURER
Invivo Corporation, Orlando, FL on 9/24/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
76
DISTRIBUTION
Distributed to the Netherlands