Recall Z-0959-2023— Getinge Usa Sales Inc

Name: FDA recall Z-0959-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-22

Class I · Ongoing

Class I FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-12-22. It names one FDA 510(k) clearance: K191027. Product: Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400. Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia..

Recalling firm: Getinge Usa Sales Inc
Classification: Class I
Status: Ongoing
Initiated: 2022-12-22
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

Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

Reason for recall

Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

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