medical Class II Updated 2019-03-13

Draegar Medical Systems, Inc. recalls Infinity Delta Family patient monitors The Infinity Delta

Recalled 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.


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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