Recall Z-1104-2021 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
| Date | Feb 10, 2021 (initiated Dec 23, 2020) |
| Status | Open, Classified |
| Reason | 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 pat |
| 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 | 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, |
| FDA record | Open on fda.gov |