Z-0974-2019Class II

Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended...

Name: Z-0974-2019 Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended...
Creator: Draegar Medical Systems, Inc.
Published: 2019-02-08
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2019-02-08 / Open, Classified / root cause: software

FDA source

Draegar Medical Systems, Inc. began a recall of Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal... on 2019-02-08. FDA classified it as Class II and gives the reason as "The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication". 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-0974-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-08
Posted: 2019-03-05
Recalling firm: Draeger Medical Systems, Inc.
Product: Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Root cause tag: software
FDA root cause: Software design
Action: On February 8, 2019, the firm, Drager, notified affected customers of the recall via an "Urgent: Medical Device Recall" letter. Customers were informed that the existing software had cybersecurity vulnerabilities and that software version VF10.1 would mitigate these issues. Customers were asked to complete a Customer Acknowledgment and Response Form and return it to Drager via fax 215-372-2940 or email to [email protected]. Your local Draeger Service representative will contact you to schedule an appointment for upgrading your systems software once a compatible version has been released for distribution. If you are aware of any incidents related to this issue or if you have any further questions regarding operation of your patient monitor, 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 again).
Quantity in commerce: 10699 in total
Distribution: US Nationwide distribution including Puerto Rico.
Product codes and lots: All software versions, all serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0974-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-13	2019-03-05
Z-0975-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-03-13	2019-03-05

Product code MHX

K152407Class IIInfinity Delta, Infinity Delta XL, Infinity KappaDraeger Medical Sytems, Inc. / cleared 2015-09-23

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)