Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Getinge Flow-i Anesthesia Systems Flow-i C20 Recalled by Getinge Usa Sales Inc Due to Due to a software bug, under certain conditions,...

Date: December 22, 2022
Company: Getinge Usa Sales Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Getinge Usa Sales Inc directly.

Affected Products

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

Quantity: 8,016 Total (7,766 OUS; 250 US)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Getinge Usa Sales Inc

Getinge Usa Sales Inc has 48 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report