Draeg Medical recalls Infinity M540 patient monitors with software versions VG4.1.1 or lower due to cybersecurity risks that could cause device reboots and loss of alarm functions.
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Draeg Medical is recalling certain Infinity M540 patient monitors that have cybersecurity vulnerabilities. These devices could reboot, lose alarm functions, or disconnect from the Infinity Network, potentially affecting patient safety.
Cybersecurity vulnerabilities in the monitor software could cause the device to reboot unexpectedly, stop working alarms, or lose communication with the Infinity Network. This might lead to missed patient alerts or disconnected monitoring during critical medical situations.
Healthcare providers using the Infinity M540 patient monitors with model numbers MS25510, MS25520, or MS26372 and software versions VG4.1.1 or lower are affected. Patients in medical facilities using these monitors are most at risk.
Check for model numbers MS25510, MS25520, or MS26372 on the monitor. The software version should be VG4.1.1 or lower. These monitors were sold with the Infinity Acute Care System (IACS) Monitoring Solution.
Look for the software version on the monitor; if it is VG4.1.1 or lower, it is part of the recall.
Draeg Medical Systems will provide updates on how to address the issue through their official channels.
If your monitor has model numbers MS25510, MS25520, or MS26372 and software version VG4.1.1 or lower, it is part of this recall.
The official recall notice does not specify a fix; contact Draeg Medical Systems for updates.
No, the recall does not require immediate stop use; healthcare providers should monitor for issues and contact Draeg Medical Systems.
We’ve drafted a message you can send Draeg: Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0258-2020 — Draeg: Medical Systems Draeg: Medical Systems Hello, I own a Draeg: Medical Systems that is covered by recall Z-0258-2020 from Draeg: Medical Systems. 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.
