Recall Z-1181-2021— Getinge Group Logistics America, LLC

Name: FDA recall Z-1181-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-29

Class II · Terminated

Class II FDA medical device recall by Getinge Group Logistics America, LLC, initiated 2021-01-29, terminated 2023-09-28. It names one FDA 510(k) clearance: K191027. 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.. Reason: 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..

Recalling firm: Getinge Group Logistics America, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-01-29
Terminated: 2023-09-28
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

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.

Reason for recall

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.

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