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Draegar Medical Systems, Inc. recalls The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos.
Recalled November 6, 2019 · FDA recall Z-0258-2020 · Draegar Medical Systems
Hazard
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. · FDA Class II
Units
5634
Sold at
US Nationwide distribution.
Description
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Product
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Manufacturer(s)
Draegar Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →