Recall Z-0422-2023— Getinge Usa Sales Inc

Name: FDA recall Z-0422-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-07

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-11-07. It names one FDA 510(k) clearance: K191027. Product: Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900). Reason: 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..

Recalling firm: Getinge Usa Sales Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-07
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB·cleared 2020-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.