# FDA recall Z-0372-2020

> **Draegar Medical Systems, Inc.** · Class II · device recall initiated 2019-10-09.

## Product

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

## Reason for recall

The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0372-2020
- **Recalling firm:** Draegar Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-09
- **Report date:** 2019-11-20

- **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-0372-2020

## Citation

> AI Analytics. FDA recall Z-0372-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0372-2020. Source: US FDA. Licensed CC0.

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