Device product
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Z-0258-2020
Product summary
- Event
- Event 83889
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5634
- Official record key
device-enforcement:Z-0258-2020
Official wording
Reason: Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Code information: Software version VG4.1.1/VG4.0.3 and lower
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
Cybersecurity vulnerabilities