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Getinge Group Logistics America, LLC recalls Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventil
Recalled March 17, 2021 · FDA recall Z-1181-2021 · Getinge Group Logistics America
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. · FDA Class II
Units
144 units
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Getinge Group Logistics America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →