Device product
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
Z-0974-2019
Product summary
- Event
- Event 82014
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10699 in total
- Official record key
device-enforcement:Z-0974-2019
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