Home / Recalls / Draegar Medical Systems, Inc. / Z-1104-2021

Z-1104-2021 Class II Ongoing

Recalled by Draegar Medical Systems, Inc. — Andover, MA

FDA device recall Z-1104-2021 was initiated by Draegar Medical Systems, Inc. on December 23, 2020 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 19802 systems (Domestic: 3412, Foreign 16,390).

Recall Details

Product Type: Devices
Report Date: February 17, 2021
Initiation Date: December 23, 2020
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19802 systems (Domestic: 3412, Foreign 16,390)

Product Description

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.

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.

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.

Code Information

Model Number - MS25510, MS25520, MS26372 Revisions 24 to 29

Other recalls by Draegar Medical Systems, Inc.

Z-1012-2022 Class II — Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For (March 4, 2022)
Z-0372-2020 Class II — Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, M (October 9, 2019)
Z-0258-2020 Class II — The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone In (September 13, 2019)
Z-0974-2019 Class II — Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta (February 8, 2019)
Z-0975-2019 Class II — Omega Systems These devices are intended to be used in the environment where (February 8, 2019)
Z-1813-2018 Class II — Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, (March 28, 2018)
Z-1382-2018 Class II — Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, (February 21, 2018)
Z-0942-2018 Class II — INFINITY DUAL HEMO MCable Pod (October 4, 2017)
Z-2734-2017 Class II — Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK3 (June 6, 2017)
Z-1772-2017 Class II — Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Ox (March 28, 2017)