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

FDA device recall Z-1104-2021 · posted 2021-02-10 · Open, Classified

Recall details

Recalling firm

Draegar Medical Systems, Inc.

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.

Action taken

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

Status

Open, Classified

Product code

MHX

Quantity affected

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, S

Date initiated

2020-12-23

Date posted

2021-02-10

Location

Andover, MA

Related 510(k) clearances