Use cautionMedical device recall · FDA · Published September 13, 2019
Draeg Medical Infinity M540 Monitor Cybersecurity Recall: Reboot Risks
Draeg Medical recalls Infinity M540 patient monitors with software versions VG4.1.1 or lower due to cybersecurity risks that could cause device reboots and loss of alarm functions.
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Take action
Contact the company
📍Recalling firmDraegar Medical Systems, Inc.6 Tech Dr · Andover, MA 01810-2434
“Draeg Medical Infinity M540 Monitor Cybersecurity Recall: Reboot Risks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67020-draeg-medical-infinity-m540-monitor-cybersecurity-recall-reboot-risks. Based on FDA recall #Z-0258-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0258-2020%22&limit=1).
The FDA announced on 2019-09-13 that Draegar Medical Systems, Inc. is recalling The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor due to cybersecurity vulnerabilities. These flaws may cause the device to reboot, lose alarm functionality, or lose communication with the cockpit and/or the Infinity Network.
How to tell if you have it
Brand: Draegar Medical Systems
Product: The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor
Model numbers: MS25510, MS25520, MS26372
Software versions: VG4.1.1/VG4.0.3 and lower
Quantity: 5634 units
Distribution: US Nationwide
The hazard
Cybersecurity vulnerabilities may cause the device to reboot, lose alarm functionality, and/or lose communication with the cockpit and/or the Infinity Network.
Context
GovInfoNow's records show Draegar Medical Systems, Inc. has 8 other recalls on record since 2017-06-06. Other recent recalls of similar products include Draegar Infinity CentralStation Software Versions VG2.1.2 and VG2.1.2 SU12: Temporary Loss of Central Monitoring (2022-03-04) and Draegar Infinity M540 Patient Monitor May Reboot Randomly - Recall (2020-12-23). Other recent recalls of similar products include Edan Diagnostics Patient Monitor Recall: Cybersecurity Risks for Elite V5/V6/V8 Models (2025-10-24), Edan iM20 Patient Monitor Recall: Cybersecurity Risks (2025-10-24), and Edan Vital Signs Monitor M3B: Cybersecurity Risk - Recall Notice (2025-10-24).
How to tell if you have this one
Check for model numbers MS25510, MS25520, or MS26372 on the monitor. The software version should be VG4.1.1 or lower. These monitors were sold with the Infinity Acute Care System (IACS) Monitoring Solution.
Brand
Draeg: Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version on the monitor; if it is VG4.1.1 or lower, it is part of the recall.
Contact Manufacturer
Draeg Medical Systems will provide updates on how to address the issue through their official channels.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0258-2020 (September 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0258-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.