# FDA recall Z-0975-2019

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

## 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.

## 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-0975-2019
- **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-0975-2019

## Citation

> AI Analytics. FDA recall Z-0975-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0975-2019. Source: US FDA. Licensed CC0.

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