Z-2189-2024Class II

Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21...

Name: Z-2189-2024 Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21...
Creator: Draeger Medical Systems, Inc.
Published: 2024-05-13
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2024-05-13 / Open, Classified / root cause: design

FDA source

Draeger Medical Systems, Inc. began a recall of Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 on 2024-05-13. FDA classified it as Class II and gives the reason as "Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2189-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-13
Posted: 2024-06-25
Recalling firm: Draeger Medical Systems, Inc.
Product: Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
Root cause tag: design
FDA root cause: Device Design
Action: On May 13, 2024, the firm began notifying affected customers of the recall through letters titled "Urgent - Medical Device Correction". Customers were informed of the issue and given additional precautions to inspect the patient cables and probes, and to discard damaged or compromised accessories. Customers will be contacted by their local Draeger Service representative to arrange for modification of the affected M500 units to be carried out free of charge as soon as the material for modification is available. If you have any questions regarding the operation of the Product, please contact Drager Service Technical Support between the hours of 8:00 AM - 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1). If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM -4:30 PM EST at 267-664-1131 or via email at [email protected].
Quantity in commerce: 34,102 units
Distribution: US Nationwide distribution. International distribution to Afghanistan, Argentina, Armenia, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Malaysia, Malta, Martinique, Mexico, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
Product codes and lots: Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2189-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2189-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25

Product code MHX

K203088Class IIInfinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc. / cleared 2022-02-01

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)