Draeger recalls Infinity CentralStation software versions VG2.1.3 and lower. Narrow waveforms may cause ECG errors in patient monitoring. Affected units have specific UDI-DI codes.
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 CentralStation software versions VG2.1.3 and lower. This software issue can cause ECG waveforms to display inaccurately, potentially leading to incorrect patient monitoring.
The software drops peaks on narrow waveforms, causing the Infinity M300 to fail frequency and impulse response tests. This may display ECG waveforms with unusually narrow QRS complexes that have lower amplitudes than actual.
Healthcare providers using the Infinity CentralStation with affected software versions are most at risk. Patients monitored by this system could experience inaccurate ECG readings.
Check for software versions VG2.1.3 and lower on the Infinity CentralStation. Affected units have UDI-DI codes starting with 04049098001878.
Install the latest software version from Draeger to fix the issue.
Software versions VG2.1.3 and lower.
Check for software versions VG2.1.3 and lower or UDI-DI codes starting with 04049098001878.
The recall addresses potential ECG waveform errors, but no specific injury risks are mentioned.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-1471-2023 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-1471-2023 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.
