Invivo recalls Xper Flex Cardio Physiomonitoring System software version 1.6.0.0388 due to potential freezing of invasive blood pressure readings during certain actions. Affected units have specific serial numbers listed in the recall notice.
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
Invivo is recalling a specific software version of their Xper Flex Cardio Physiomonitoring System because blood pressure readings may freeze when certain functions are used. This could lead to inaccurate monitoring of a patient's vital signs during medical procedures.
The software may freeze invasive blood pressure (IBP) numeric values when users perform specific actions like changing site labels, toggling waveform displays, or using the pullback feature. This could result in inaccurate blood pressure readings during medical monitoring.
Healthcare providers using the Xper Flex Cardio Physiomonitoring System with the affected software version are most at risk. Patients receiving monitoring through this system could experience inaccurate blood pressure readings.
Check for the software version 1.6.0.0388 on the Xper Flex system. Affected units have specific serial numbers listed in the recall notice, including US1814000001 through US1814000096.
Verify the software version on your Xper Flex Cardio Physiomonitoring System. If it is 1.6.0.0388, it is affected.
The recall states that blood pressure readings may freeze during certain actions, but it does not specify that this causes injury or serious harm. The risk is considered low.
Check if your software version is 1.6.0.0388 and if your system has one of the listed serial numbers (US1814000001 through US1814000096).
The recall does not provide a remedy, so there is no action required beyond checking your software version and serial number.
We’ve drafted a message you can send Invivo to request your refund or repair — edit it as you like.
Subject: Recall Z-0462-2019 — Invivo Invivo Hello, I own a Invivo that is covered by recall Z-0462-2019 from Invivo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
