Draegar Medical Systems, Inc. recalls Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Pro…

Recall date

February 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0975-2019

FDA classification

Class II

Brand / firm

Draegar Medical Systems, Inc.

Sold / distributed

US Nationwide distribution including Puerto Rico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.