Company: Draegar Medical Systems, Inc.
Date of Enforcement Report: 11/20/2019
Class II

PRODUCT

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

• Recall Number: Z-0372-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Draegar Medical Systems, Inc. on 10/9/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

12204

DISTRIBUTION

US nationwide distribution.