Device 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.
Z-0975-2019
Product summary
- Event
- Event 82014
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10699 in total
- Official record key
device-enforcement:Z-0975-2019
Official wording
Reason: 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.
Code information: All software versions, all serial numbers.
Distribution pattern: US Nationwide distribution including Puerto Rico.
Derived failure modes
-
Device software or design
cybersecurity vulnerabilities