Draegar Medical Systems, Inc. recalls The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos.…
- Recall date
- September 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0258-2020
- FDA classification
- Class II
- Brand / firm
- Draegar Medical Systems, Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
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