Z-0372-2020Class II

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755...

Name: Z-0372-2020 Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755...
Creator: Draegar Medical Systems, Inc.
Published: 2019-10-09
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2019-10-09 / Open, Classified / root cause: software

FDA source

Draegar Medical Systems, Inc. began a recall of Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 on 2019-10-09. FDA classified it as Class II and gives the reason as "The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0372-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-09
Posted: 2019-11-14
Recalling firm: Draeger Medical Systems, Inc.
Product: Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Recall notification letter dated 10/9/19 was sent to customers. Recommended cybersecurity precautions: While we are in the process of updating the software, we recommend that you follow best recommended practices to limit access to the devices and wireless network: " Physical security of the patient monitors is recommended and is the responsibility of the operating organization. " Physical security boundaries to prevent access to your facility's network infrastructure is recommended and is the responsibility of the operating organization. " Drager relies on the medical device isolation mechanism of the VLANs and the proper configuration, implementation, and use of the operating organization's security measures to prevent the introduction of malware onto the Infinity Network. Action required: Please complete the attached Acknowledgement and Response Form and return it to Drager per instructions included on the form. The software upgrade will be provided free of charge. The upgrade path for your M300 device is dependent on the part number of your M300s currently in use. Your local Drager representative will contact you prior to the availability of software version VG2.3.2 to discuss the upgrade path. If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM - 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Quantity in commerce: 12204
Distribution: US nationwide distribution.
Product codes and lots: All systems using Software version VG2.3.1 and lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0372-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0372-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-20	2019-11-14

Product code MHX

K130711Class IIInfinity Centralstation with Infinity M300Draeger Medical Systems, Inc. / cleared 2013-04-11

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)