Lower riskMedical device recall · FDA · Published December 23, 2020
Draegar Infinity M540 Patient Monitor May Reboot Randomly - Recall
Draegar Medical Systems recalls Infinity M540 patient monitors (model MS25510, MS25520, MS26372, revisions 24-29) that may randomly reboot causing temporary disconnection from patient monitoring. This could lead to interrupted care if the error repeats.
The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
Take action
Contact the company
📍Recalling firmDraegar Medical Systems, Inc.6 Tech Dr · Andover, MA 01810-2434
“Draegar Infinity M540 Patient Monitor May Reboot Randomly - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63609-draegar-infinity-m540-patient-monitor-may-reboot-randomly-recall. Based on FDA recall #Z-1104-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1104-2021%22&limit=1).
The FDA announced on 2020-12-23 that Draegar Medical Systems, Inc. is recalling Infinity Acute Care System (IACS) Monitoring Solution devices due to a hazard where the monitor may randomly reboot or enter a fail-state. This Class II recall affects approximately 19,802 systems distributed worldwide.
How to tell if you have it
Brand: Draegar Medical Systems
Product: Infinity Acute Care System (IACS) Monitoring Solution
Model Numbers: MS25510, MS25520, MS26372
Revisions: 24 to 29
The hazard
According to the FDA, the Infinity M540 patient monitor may randomly reboot due to an error in transmitting and reading header data. If the device reboots three times within 10 minutes, it enters a fail-state that triggers a continuous sound alert and resets to factory defaults.
Context
GovInfoNow's records show Draegar Medical Systems, Inc. has had 8 other recalls on record since 2017-06-06. Other recent recalls of similar products include Philips IntelliVue MX40 (2025-10-31), Philips IntelliVue MX70 (2025-10-31), and Philips IntelliVue MX60 (2025-10-31).
How to tell if you have this one
Check for model numbers MS25510, MS25520, or MS26372 with revisions 24 through 29. The product is sold for use by healthcare professionals in clinical settings.
Brand
Draegar Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Monitor Status
Look for a continuous sound indicating the fail-state; if present, stop using the monitor immediately.
Reconfigure Monitor
After the device resets to factory defaults, manually reconfigure the monitor to resume patient monitoring.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WY and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 56 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-1104-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1104-2021 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.