Home / Recalls / Medical Devices
Getinge Usa Sales Inc recalls Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Recalled December 14, 2022 · FDA recall Z-0422-2023 · Getinge Usa Sales
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. · FDA Class II
Units
65 US
Sold at
US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
Description
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.
Product
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Manufacturer(s)
Getinge Usa Sales Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →