Edan Diagnostics recalls iM20 Patient Monitors due to potential cybersecurity vulnerabilities. Affected units have serial numbers listed in the recall notice. Consumers should contact Edan for guidance.
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 Diagnostics is recalling its iM20 Patient Monitors because of potential cybersecurity issues. These devices could be vulnerable to hacking, which might compromise patient safety. The recall affects specific models with listed serial numbers.
The recall is due to potential cybersecurity vulnerabilities identified by the FDA. These vulnerabilities could allow unauthorized access to the device's data, potentially compromising patient safety through hacking or data breaches.
Healthcare providers and patients using Edan iM20 Patient Monitors with the listed serial numbers are affected. Medical facilities that have these devices on-site are most at risk.
Check if your iM20 Patient Monitor has a serial number listed in the provided list of serial numbers (e.g., 260502-M17A03230001).
Look for the serial number on your iM20 Patient Monitor to see if it matches the list provided in the recall notice.
Edan Diagnostics is recalling the iM20 Patient Monitors due to potential cybersecurity vulnerabilities identified by the FDA.
Check if your device's serial number appears in the list of serial numbers provided in the recall notice.
Contact Edan Diagnostics for guidance on next steps.
We’ve drafted a message you can send Edan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1147-2026 — Edan Diagnostics Edan Diagnostics Hello, I own a Edan Diagnostics that is covered by recall Z-1147-2026 from Edan Diagnostics. 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.
