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Draegar Medical Systems, Inc. recalls Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare P
Recalled March 13, 2019 · FDA recall Z-0975-2019 · Draegar Medical Systems
Hazard
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. · FDA Class II
Units
10699 in total
Sold at
US Nationwide distribution including Puerto Rico.
Description
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.
Product
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.
Manufacturer(s)
Draegar Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →