Z-1104-2021Class II

Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic...

Name: Z-1104-2021 Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic...
Creator: Draegar Medical Systems, Inc.
Published: 2020-12-23
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2020-12-23 / Open, Classified / root cause: software

FDA source

Draegar Medical Systems, Inc. began a recall of Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and... on 2020-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1104-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-23
Posted: 2021-02-10
Recalling firm: Draeger Medical Systems, Inc.
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 19802 systems (Domestic: 3412, Foreign 16,390)
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 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.
Product codes and lots: Model Number - MS25510, MS25520, MS26372 Revisions 24 to 29

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1104-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1104-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-17	2021-02-10

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)