Z-1382-2018Class II

Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724...

Name: Z-1382-2018 Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724...
Creator: Draegar Medical Systems, Inc.
Published: 2018-02-21
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2018-02-21 / Terminated / root cause: software

FDA source

Draegar Medical Systems, Inc. began a recall of Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196... on 2018-02-21. FDA classified it as Class II and gives the reason as "The invasive pressure visual and audible alarms may not activate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1382-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-21
Posted: 2018-04-16
Terminated: 2020-04-20
Recalling firm: Draeger Medical Systems, Inc.
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The invasive pressure visual and audible alarms may not activate.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: 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.
Quantity in commerce: 28317 total products
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 codes and lots: Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1382-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-16

Product code MHX

K113798Class IIInfinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc. / cleared 2012-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)