FDA-Device2018-09-26Class II
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Invivo Corporation
Hazard
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.
Sold states
Distribution in the Netherlands
Affected count
38
Manufactured in
12151 Research Pkwy Ste 200, N/A, Orlando, FL, United States
Products
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3192-2018Don't want to check this manually?
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