Apr

2023

Recall: Software Drops Peaks on Narrow Waveforms

Company: Draeger Medical Systems, Inc.
Date of Enforcement Report: 4/27/2023
Class II

PRODUCT

Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

Recall Number:

Z-1471-2023

REASON:

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

RECALLING FIRM/MANUFACTURER:

Draeger Medical Systems, Inc

VOLUME OF PRODUCT IN COMMERCE:

6803 systems

DISTRIBUTION:

Worldwide – US Nationwide distribution.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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Recall: Software Drops Peaks on Narrow Waveforms

Allison Pate

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