# FDA recall Z-0974-2019

> **Draegar Medical Systems, Inc.** · Class II · device recall initiated 2019-02-08.

## 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.

## Reason for recall

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.

## Distribution

US Nationwide distribution including Puerto Rico.

## Key facts

- **Recall number:** Z-0974-2019
- **Recalling firm:** Draegar Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-02-08
- **Report date:** 2019-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0974-2019

## Citation

> AI Analytics. FDA recall Z-0974-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0974-2019. Source: US FDA. Licensed CC0.

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