FDA-Device2019-03-13Class II
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.
Draegar Medical Systems, Inc.
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.
Sold states
US Nationwide distribution including Puerto Rico.
Affected count
10699 in total
Manufactured in
6 Tech Dr, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0975-2019Don't want to check this manually?
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