Draegar Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0975-2019)

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:

Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

Product Classification:

Class II

Date Initiated: February 8, 2019

Date Posted: March 13, 2019

Recall Number: Z-0975-2019

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