Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is Recalled by Draegar Medical Systems, Inc. Due to The Infinity M540 patient monitor may randomly reboot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Draegar Medical Systems, Inc. directly.
Affected Products
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
Quantity: 19802 systems (Domestic: 3412, Foreign 16,390)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Draegar Medical Systems, Inc.
Draegar Medical Systems, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report