medical Class II Updated 2019-11-06

Draegar Medical Systems, Inc. recalls The Infinity Acute Care System (IACS) Monitoring Solution wi

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version VG4.1.1/VG4.0.3 and lower
View official government recall

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