Draegar Medical Systems, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Draegar Medical Systems, Inc.
Lot Codes / Batch Numbers
Model Number - MS25510, MS25520, MS26372 Revisions 24 to 29
Products Sold
Model Number - MS25510, MS25520, MS26372 Revisions 24 to 29
Draegar Medical Systems, Inc. is recalling Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, phy due to 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 dev. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 01/2021, Draeger issued Urgent Medical Device Correction notices via certified mail. The purpose of the letter is to advise customers that Draeger is voluntarily recalling our Infinity Acute Care System and the Standalone Infinity M540 patient monitors due to a software issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026