Infinity Acute Care System (IACS) Monitoring Solution… recallZ-1382-2018 · Draegar Medical Systems, Inc. · initiated Feb 21, 2018
Terminated
Is my device affected?
- 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.
- 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.
- 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 invasive pressure visual and audible alarms may not activate.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
On February 21, 2018 , Drager Medical Systems Inc. mailed an Urgent Medical Device Recall Notification to affected customers, affected customers that informs the end users of the recommended connecting sequence when using the hemodynamic pod with the M540 patient monitor. A Customer Reply Card will be included as a receipt from the customers that they received and acknowledged the recommended sequence when using the hemodynamic pod with the M540 patient monitor. To avoid encountering the identified issue, the user should follow the below identified steps whenever the hemodynamic pod is plugged into the Infinity M540 patient monitor and the unit is placed in Standby. When the user is ready to monitor the patient: 1. Exit Standby mode 2. Unplug, pause for a minimum of 3 seconds and re-plug the hemodynamic pod 3. Continue per your normal procedure If there are any questions regarding the notification please call 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Drager Infinity Acute Care System (IACS) please contact Drager Service Technical Support at 1-800-437-2437 (press 4 at the prompt and then 4 again). For further questions, please call (978) 379-8077.
Recall details
- Recall number
- Z-1382-2018
- Status
- Terminated
- Initiated by the company
- Feb 21, 2018
- Recalling firm
- Draegar Medical Systems, Inc.
- Quantity
- 28317 total products
- Product code
- MHX
- FDA submissions
- K113798
- Distribution
- Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Monaco, Mozambique, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.
Product description
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
Code information (models, lots, serial numbers)
Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- SHP UNT INFINITY M540 MS20401Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls5 deaths62 reports
- INFINITY M500 WITH POWER MS20407Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)3 recalls2 reports
- IACS w/C700 MS25520Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls1 death27 reports
- IACS w/C500 MS25510Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls2 deaths25 reports
- Infinity M540 MS26372Draeger Medical Systems, Inc. · System,Network And Communication,Physiological Monitors2 recalls9 reports
Other devices under the same FDA submission
1 device cleared under K113798 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Infinity Mpod Quad Hemo MS20725Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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