FDA Device recall Z-0258-2020
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor
- FDA Device
- Class II
- ongoing
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor by Draegar Medical Systems, citing cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0258-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-13 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Draegar Medical Systems |
| Distribution | US |
Product
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Reason
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Identifiers
| code_info | Software version VG4.1.1/VG4.0.3 and lower |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0258-2020%22
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