FDA-Device2023-02-01Class I
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Getinge Usa Sales Inc
Hazard
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Sold states
US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.
Affected count
8,016 Total (7,766 OUS; 250 US)
Manufactured in
1 Geoffrey Way, N/A, Wayne, NJ, United States
Products
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2023Don't want to check this manually?
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