Draeger recalls Infinity M300 and M300+ monitors with outdated software that may display inaccurate ECG waveforms. Affected units have specific UDI-DI codes and software versions. Contact for repair or replacement.
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.
Draeger is recalling Infinity M300 and M300+ patient monitors that have outdated software. This software issue can cause ECG waveforms to show incorrect measurements, potentially leading to misdiagnosis or treatment errors.
The software drops peaks on narrow waveforms, causing the monitor to fail ECG tests. This may display ECG waveforms with QRS amplitudes lower than actual, potentially leading to misdiagnosis if the waveforms are narrow or high frequency.
Healthcare professionals using these monitors for ECG and pulse oximetry on patients. The risk is highest for those monitoring critically ill patients with narrow QRS waveforms.
Check for UDI-DI codes: 04049098048989 (M300) or 04049098095778 (M300+). Also look for software versions 2.4 or lower. These monitors are used with the Infinity patient monitoring network.
Verify your monitor's software version; affected units run versions 2.4 or lower.
Reach out to Draeger for repair or replacement of the monitor.
The software on the Infinity CentralStation drops peaks on narrow waveforms, causing the monitor to fail ECG tests. This may display ECG waveforms with QRS amplitudes lower than actual.
Infinity M300 and M300+ monitors with UDI-DI codes 04049098048989 (M300) or 04049098095778 (M300+).
No, but you should check the software version and contact Draeger for repair or replacement.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-1472-2023 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-1472-2023 from Draeger. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
