medical Class II Updated 2019-03-13

Draegar Medical Systems, Inc. recalls Omega Systems These devices are intended to be used in th

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All software versions, all serial numbers.
View official government recall

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