Edan recalls Central Monitoring System (MFM-CMS) devices due to potential cybersecurity issues identified by FDA. Affected units include specific serial numbers and model codes. No immediate action is required but security updates are recommended.
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 is recalling its Central Monitoring System (MFM-CMS) devices after receiving an FDA letter about potential cybersecurity issues. This could allow unauthorized access to medical device data, but no specific injuries have been reported.
The recall involves potential cybersecurity vulnerabilities that could allow unauthorized access to medical device data. However, the FDA letter indicates no specific incidents of data breaches or injuries have occurred.
Healthcare providers and medical facilities using Edan's Central Monitoring System (MFM-CMS) devices are likely affected. Patients using these systems are at minimal risk as the issue relates to data security rather than direct harm.
Check for the model code MFM-CMS and serial numbers listed in the recall notice. Affected units include specific serial numbers and model codes starting with 261432-M and 262237-M.
Identify your device model and serial number to confirm if it is affected by this recall.
Contact Edan Diagnostics for guidance on security updates if your device is affected.
The recall addresses potential cybersecurity issues identified by the FDA, but no specific injuries or data breaches have been reported. The risk is low.
No immediate action is required. The recall does not mandate stopping use but recommends checking for security updates.
Check your device's model code and serial number against the list provided in the recall notice.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1150-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1150-2026 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.
