Edan Diagnostics recalls iX10, iX12, and iX15 patient monitors due to potential cybersecurity vulnerabilities. Affected units have specific serial numbers; 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 Diagnostics is recalling its iX10, iX12, and iX15 patient monitors because of potential cybersecurity issues. This recall is based on an FDA alert about vulnerabilities that could be exploited by hackers.
The recall is triggered by an FDA alert about potential cybersecurity vulnerabilities in the devices. These vulnerabilities could allow hackers to access the patient monitor's systems, potentially compromising patient data or device functionality.
Healthcare facilities and medical professionals using the iX10, iX12, or iX15 patient monitors are likely affected. Patients using these monitors could be at risk if the device is compromised by cyberattacks.
Check for the model numbers iX10, iX12, or iX15 on the device. Affected units have specific serial numbers listed in the recall notice, which include a range of numbers starting with 262541 or 262542.
Look for the model number on the device label to confirm if it's iX10, iX12, or iX15.
Reach out to Edan Diagnostics for specific instructions on how to verify if your device is affected and what to do next.
Edan Diagnostics is recalling these patient monitors due to an FDA alert about potential cybersecurity vulnerabilities that could be exploited by hackers.
Check the model number on your device (iX10, iX12, or iX15) and compare the serial numbers listed in the recall notice.
Contact Edan Diagnostics directly for specific instructions on how to verify and address the issue.
We’ve drafted a message you can send Edan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1149-2026 — Edan Diagnostics Edan Diagnostics Hello, I own a Edan Diagnostics that is covered by recall Z-1149-2026 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.
