Edan recalls Vital Signs Monitor M3A models due to potential cybersecurity issues. Affected units may have vulnerabilities that could be exploited by hackers. Contact Edan for details.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan is recalling its Vital Signs Monitor M3A models because they have potential cybersecurity vulnerabilities that could be exploited by hackers. This is a security issue, not a physical hazard.
The device has potential cybersecurity vulnerabilities that could be exploited by hackers. This means unauthorized access to the device's data could occur if the device is connected to a network without proper security measures.
Healthcare professionals who own or use the Edan Vital Signs Monitor M3A models are affected. The risk is low as this is a cybersecurity issue, not a physical hazard.
Check if your monitor has the model number M3A and serial numbers listed in the recall notice (e.g., 260760-M16406920062).
Verify your monitor's model number and serial number against the list provided in the recall notice.
No, this is a cybersecurity issue. The device itself is not physically dangerous, but it could be vulnerable to unauthorized access if connected to a network without proper security.
Check if your monitor has the model number M3A and a serial number listed in the recall notice (e.g., 260760-M16406920062).
Contact Edan directly for instructions on how to secure your device or return it if needed.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1153-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1153-2026 from Edan. 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.
