# FDA recall Z-1472-2023

> **Draeger Medical Systems, Inc.** · Class II · device recall initiated 2023-04-05.

## Product

Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,

## Reason for recall

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1472-2023
- **Recalling firm:** Draeger Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-05
- **Report date:** 2023-05-03

- **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-1472-2023

## Citation

> AI Analytics. FDA recall Z-1472-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1472-2023. Source: US FDA. Licensed CC0.

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