FDA-Device2022-12-14Class II
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Getinge Usa Sales Inc
Hazard
The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
Sold states
US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
Affected count
65 US
Manufactured in
1 Geoffrey Way, N/A, Wayne, NJ, United States
Products
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2023Don't want to check this manually?
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