Recall Z-0462-2019— Invivo Corporation
Class II · Completed
Class II FDA medical device recall by Invivo Corporation, initiated 2018-09-24. It names one FDA 510(k) clearance: K101571. Product: Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388. 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
- Invivo Corporation
- Classification
- Class II
- Status
- Completed
- Initiated
- 2018-09-24
- Firm location
- Orlando, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.