Draegar Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0974-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 8, 2019

Date Posted: March 13, 2019

Recall Number: Z-0974-2019

Event ID: 82014

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.

Status: Ongoing

Product Quantity: 10699 in total

Code Information:

All software versions, all serial numbers.

Distribution Pattern:

US Nationwide distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated