FDA-Device2019-11-06Class II
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Draegar Medical Systems, Inc.
Hazard
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Sold states
US Nationwide distribution.
Affected count
5634
Manufactured in
6 Tech Dr, Andover, MA, United States
Products
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0258-2020Don't want to check this manually?
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