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Infinity Acute Care System (IACS) Monitoring Solution recallZ-1104-2021 · Draegar Medical Systems, Inc. · initiated Dec 23, 2020

Class II Open, Classified All recalls posted in February 2021

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draegar Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1104-2021
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 23, 2020
Posted by the FDA
Feb 10, 2021
Recalling firm
Draegar Medical Systems, Inc.
Quantity
19802 systems (Domestic: 3412, Foreign 16,390)
Product code
MHX
FDA submissions
K093788, K113798
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 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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

5 devices cleared under K093788, K113798 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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