Draegar Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0258-2020)

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:

The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

Product Classification:

Class II

Date Initiated: September 13, 2019

Date Posted: November 6, 2019

Recall Number: Z-0258-2020

Event ID: 83889

Reason for Recall:

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

Status: Ongoing

Product Quantity: 5634

Code Information:

Software version VG4.1.1/VG4.0.3 and lower

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated