FDA-Device2021-03-17Class II
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Getinge Group Logistics America, LLC
Hazard
Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.
Sold states
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, MA, MI, MO, NJ, NY, OH, OR, PA, TX, VA, WA, WV.
Affected count
144 units
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1181-2021Don't want to check this manually?
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