FDA-Device2019-12-04Class II
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
ENDOTRONIX
Hazard
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
Sold states
TX, IL, GA
Affected count
58 units
Manufactured in
815 Ogden Ave, Lisle, IL, United States
Products
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2020Don't want to check this manually?
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