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.
Draegar Medical Systems is recalling Infinity M540 patient monitors that may randomly reboot due to a software error. This could cause temporary disconnection from patient monitoring, potentially interrupting care if the error repeats.
The monitor may randomly reboot due to an error in reading file headers. If this error continues and the monitor reboots three times within 10 minutes, it enters a fail-state with a continuous sound. The device then resets to factory defaults, requiring manual reconfiguration to resume monitoring.
Healthcare professionals using the Infinity M540 patient monitor for adult, pediatric, or neonatal patients. The risk is highest for those in critical care settings where continuous monitoring is essential.
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.
Look for a continuous sound indicating the fail-state; if present, stop using the monitor immediately.
After the device resets to factory defaults, manually reconfigure the monitor to resume patient monitoring.
Models MS25510, MS25520, and MS26372 with revisions 24 through 29.
The monitor will enter a fail-state with a continuous sound. You must stop using it and reconfigure it after it resets to factory defaults.
The recall does not provide a specific remedy; users must manually reconfigure the monitor after it resets to factory defaults.
We’ve drafted a message you can send Draegar Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1104-2021 — Draegar Medical Systems Draegar Medical Systems Hello, I own a Draegar Medical Systems that is covered by recall Z-1104-2021 from Draegar Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
