Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory Recalled by Getinge Usa Sales Inc Due to Device does not meet regulatory requirements of stability...

Date: July 21, 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

Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)

Quantity: US 102 units; OUS 13750 units

Why Was This Recalled?

Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk

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