FDA-Device2021-06-30Class I
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Vero Biotech, LLC
Hazard
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Sold states
Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC
Affected count
465 units
Manufactured in
387 Technology Cir Nw Ste 125, N/A, Atlanta, GA, United States
Products
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1863-2021Don't want to check this manually?
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