Infinity Acute Care System (lACS) Monitoring Solution recallZ-1813-2018 · Draegar Medical Systems, Inc. · initiated Mar 28, 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
Software anomaly resulting in the loss of patient settings and stored patient data.
FDA root cause category: Under Investigation by firm
What the company is doing
On March 28, 2018, Drager Medical Systems Inc. mailed Urgent Medical Device Recall Notifications to affected customers. The following information was included in the notification: 1) Do not use Infinity MCable Mainstream CO2 sensors revision 16 with M540 Patient Monitor, software versions VG4.1 or lower. Previous revisions of the CO2 sensor may be used. 2) We are in process of resolving this product issue. If you choose to upgrade your system(s), your Drger service representative will schedule a service visit and upgrade your M540 patient monitor(s) once the updated software is available for distribution. 3)A Customer Reply Card will be included as a receipt from the customers that they received this information and to indicate if the customer would like the revised software update once it is available. Customer with questions regarding the notification may call (800) 437-2437 (press 1 at the prompt, then 32349) Customers with questions regarding the operation and/or servicing of the Drager Infinity Acute Care System may contact Drager Service Technical Support at (800) 437-2437 (press 4 at the prompt then 4 again).
Recall details
- Recall number
- Z-1813-2018
- Status
- Terminated
- Initiated by the company
- Mar 28, 2018
- Recalling firm
- Draegar Medical Systems, Inc.
- Quantity
- 25, 629
- Product code
- MHX
- FDA submissions
- K113798
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana 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 &Tobago Turkey Turkmenistan United Kingdom USA Utd.Arab.Emir. Vietnam
Product description
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, 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 professionals. 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 Numbers:MS20401, 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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