Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version Recalled by Invivo Corporation Due to Released with an incorrect, older firmware version installed....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Invivo Corporation directly.
Affected Products
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Quantity: 38
Why Was This Recalled?
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.
Where Was This Sold?
Distribution in the Netherlands
About Invivo Corporation
Invivo Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report