# FDA recall Z-0258-2020

> **Draegar Medical Systems, Inc.** · Class II · device recall initiated 2019-09-13.

## Product

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

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0258-2020
- **Recalling firm:** Draegar Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-13
- **Report date:** 2019-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0258-2020

## Citation

> AI Analytics. FDA recall Z-0258-2020. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-0258-2020. Source: US FDA. Licensed CC0.

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