# FDA recall Z-1012-2022

> **Draegar Medical Systems, Inc.** · Class II · device recall initiated 2022-03-04.

## Product

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12.  For patient monitoring with Infinity M300 wireless telemetry devices.

## Reason for recall

Software issue resulting in temporary loss of central monitoring functionality.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.

## Key facts

- **Recall number:** Z-1012-2022
- **Recalling firm:** Draegar Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-04
- **Report date:** 2022-05-04

- **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-1012-2022

## Citation

> AI Analytics. FDA recall Z-1012-2022. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1012-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*