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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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