Class II — Potential Health Hazard

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

Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: Recalled by Draegar Medical Systems, Inc. Due to Cockpits with revision index 06 or higher that...

Date: June 6, 2017
Company: Draegar Medical Systems, Inc.
Status: Terminated
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 Draegar Medical Systems, Inc. directly.

Affected Products

Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

Quantity: 37 US and 682 OUS

Why Was This Recalled?

Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.

Where Was This Sold?

This product was distributed to 5 states: AZ, NH, SD, TN, TX

Affected (5 states)Not affected

About Draegar Medical Systems, Inc.

Draegar Medical Systems, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

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