Edan Patient Monitor models X8, X10, X12 have potential cybersecurity issues. Recalled due to FDA alert about device security risks. Stop using immediately to prevent 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 Patient Monitor models X8, X10, and X12 have been recalled because of potential cybersecurity issues identified by the FDA. These devices could be vulnerable to security breaches that might expose patient health data. Users should stop using them immediately.
The FDA has identified cybersecurity vulnerabilities in these patient monitors that could allow unauthorized access to patient health data. This risk could lead to data breaches and potential exposure of sensitive medical information.
Healthcare providers and medical facilities that own or use Edan Patient Monitors X8, X10, or X12 models are most at risk. These devices are used in clinical settings to monitor patient vital signs.
Check for the model numbers X8, X10, or X12 on your device. Look for serial/lot numbers listed in the recall notice (e.g., 261586-M21116620010, 261590-M21116640001, etc.).
Immediately stop using the patient monitor as it poses a cybersecurity risk that could expose patient health data.
The FDA has identified cybersecurity vulnerabilities in these patient monitors that could allow unauthorized access to patient health data.
Check the model number (X8, X10, or X12) and serial/lot numbers listed in the recall notice (e.g., 261586-M21116620010, 261590-M21116640001).
Stop using it immediately and contact Edan Diagnostics for further instructions.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1148-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1148-2026 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.
