Edan recalls iM3s/iM3As/iM3Bs/iHM3s vital signs monitors due to potential cybersecurity issues. Affected units have serial numbers listed in the recall notice.
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 iM3s, iM3As, iM3Bs, and iHM3s vital signs monitors because of potential cybersecurity risks. This could allow unauthorized access to health data, though the specific risk level isn't detailed in the recall notice.
The recall mentions potential cybersecurity issues that could allow unauthorized access to health data. However, the specific nature of the risk and how it might affect users is not clearly described in the notice.
Users of these medical monitors, particularly those monitoring patients with critical health conditions, are at risk. The recall affects specific serial numbers listed in the notice.
Check if your monitor has a serial number listed in the provided list (e.g., 262825-H24701480005, 261573-M21708880001). The product is intended for measuring physiological parameters in adults and children.
Compare your monitor's serial number with the list provided in the recall notice to determine if it is affected.
The recall is due to potential cybersecurity issues that could allow unauthorized access to health data, as noted in an FDA letter.
The recall notice does not specify a remedy, so you should check the list of serial numbers to confirm if your device is affected.
The recall mentions potential cybersecurity risks, but the specific health risks are not detailed in the notice.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1144-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1144-2026 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.
