Edan Diagnostics recalls Elite V5, V6, and V8 patient monitors due to potential cybersecurity vulnerabilities. Affected units may have security risks that could compromise patient data. Contact Edan for instructions.
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 Elite V5, V6, and V8 patient monitors because they may have cybersecurity issues that could lead to data breaches. This recall affects medical devices used in hospitals and clinics.
The patient monitors may have cybersecurity vulnerabilities that could allow unauthorized access to patient health data. This is a potential risk for healthcare facilities using these devices but does not pose an immediate physical danger to patients.
Healthcare providers and medical facilities that use Edan's Elite V5, V6, or V8 patient monitors are most at risk. Patients are not directly affected by the cybersecurity issue.
Check for the model numbers Elite V5, Elite V6, or Elite V8 on the device. Look for the serial numbers listed in the recall notice, which include specific combinations like 260342-M17B09290001 or 002338-M23226990001.
Identify your patient monitor model (Elite V5, V6, or V8) and check the serial number against the list provided in the recall notice.
Reach out to Edan Diagnostics for instructions on how to address the cybersecurity issue, as they have not provided a specific remedy in the recall notice.
No, patients are not directly at risk from this cybersecurity issue. The recall affects healthcare facilities that use the patient monitors.
Check the model number (Elite V5, V6, or V8) and compare the serial number to the list provided in the recall notice.
Contact Edan Diagnostics for instructions on how to address the cybersecurity issue, as they have not provided a specific remedy in the recall notice.
We’ve drafted a message you can send Edan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2026 — Edan Diagnostics Edan Diagnostics Hello, I own a Edan Diagnostics that is covered by recall Z-1146-2026 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.
