Edan's iM3 Vital Signs Monitor has cybersecurity vulnerabilities that could allow unauthorized access. Affected units have serial numbers listed in the recall. Stop using immediately to prevent potential data breaches.
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's iM3 Vital Signs Monitor has cybersecurity vulnerabilities that could allow unauthorized access to patient data. Affected units have specific serial numbers listed in the recall. Stop using immediately to prevent potential data breaches.
The device has cybersecurity vulnerabilities that could allow unauthorized access to patient health data. This could lead to potential data breaches and privacy issues, but does not cause physical harm.
Patients using the Edan iM3 Vital Signs Monitor for home healthcare are most at risk. The device measures blood pressure, oxygen levels, and other vital signs.
Check if your device has a serial number starting with '261436-M' followed by specific numbers listed in the recall. The iM3 model has three work modes for monitoring vital signs.
Immediately stop using the Edan iM3 Vital Signs Monitor as it has cybersecurity vulnerabilities that could allow unauthorized access to patient data.
The iM3 monitor has vulnerabilities that could allow unauthorized access to patient health data, potentially leading to data breaches.
Yes, contact Edan directly with your serial number to confirm if your device is affected and get instructions.
The recall record does not mention a fix or remedy for the cybersecurity issue.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1143-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1143-2026 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.
