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.