Invivo recalls Xper Flex Cardio Physiomonitoring System with faulty software version 1.6.0.0388 that may cause inaccurate ECG readings and heart rate displays. Affected units have specific serial numbers listed in the recall.
Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.
Invivo is recalling a specific software version of their Xper Flex Cardio Physiomonitoring System due to potential inaccuracies in ECG monitoring and heart rate readings. This could lead to incorrect medical assessments if the device is used for patient monitoring.
The device was released with an older firmware version that causes intermittent loss of ECG monitoring, inaccurate ECG amplitude display, and incorrect heart rate readings. This happens due to a QRS detection fault in the software.
Healthcare professionals using the Xper Flex Cardio Physiomonitoring System with the specified software version and serial numbers are affected. Patients relying on this device for continuous monitoring may be at risk of inaccurate readings.
Check if your Xper Flex Cardio Physiomonitoring System has software version 1.6.0.0388 and one of the listed serial numbers: US1814000001 through US1814000072.
Contact Invivo Corporation to update to the corrected software version 1.6.0.0388 or later.
The recall addresses potential inaccuracies in ECG readings and heart rate displays, but the risk is low as the issue is software-related and does not cause immediate harm.
Check if your Xper Flex Cardio Physiomonitoring System has software version 1.6.0.0388 and one of the serial numbers listed in the recall notice.
No, the device can continue to be used safely after updating to the corrected software version.
We’ve drafted a message you can send Invivo to request your refund or repair — edit it as you like.
Subject: Recall Z-3192-2018 — Invivo Invivo Hello, I own a Invivo that is covered by recall Z-3192-2018 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.
