FDA-Device2024-05-22Class II
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
Fresenius Medical Care Holdings, Inc.
Hazard
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
Sold states
US Nationwide distribution.
Affected count
88 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1822-2024Don't want to check this manually?
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