Home / Recalls / Medical Devices
Invivo Corporation recalls Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Recalled September 26, 2018 · FDA recall Z-3192-2018 · Invivo
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. · FDA Class II
Units
38
Sold at
Distribution in the Netherlands
Description
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.
Product
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Manufacturer(s)
Invivo Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →