Class II — Potential Health Hazard

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

The Infinity Acute Care System (IACS) Monitoring Solution with the Recalled by Draegar Medical Systems, Inc. Due to Cybersecurity vulnerabilities may cause device to reboot, lose...

Date: September 13, 2019
Company: Draegar Medical Systems, 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 Draegar Medical Systems, Inc. directly.

Affected Products

The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

Quantity: 5634

Why Was This Recalled?

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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