Recall – Telemetry monitoring system software cybersecurity vulnerabilities

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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

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