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Open, Classified

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.

FDA Recall Z-1104-2021 · Posted 2021-02-10

Recalling FirmDraegar Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2020-12-23
Product Quantity19802 systems (Domestic: 3412, Foreign 16,390)

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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 countries of Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Monaco, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir., Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113798INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc. · 2012-03-22K093788INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTIONDraeger Medical Systems, Inc. · 2010-03-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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