Draegar Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0372-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 9, 2019

Date Posted: November 20, 2019

Recall Number: Z-0372-2020

Event ID: 84028

Reason for Recall:

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

Status: Ongoing

Product Quantity: 12204

Code Information:

All systems using Software version VG2.3.1 and lower

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated