FDA recall Z-0422-2023

Getinge Usa Sales Inc · Class II · device

Product

Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

Reason for recall

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.

Distribution

US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.

Key facts

Status
Ongoing
Initiation date
2022-11-07
Report date
2022-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2023