Edan Diagnostics recalls Central Monitoring Systems MFM-CNS and MFM-CNS Lite due to potential cybersecurity issues. These software applications manage fetal monitoring data and maternal vital signs. Affected units have specific serial numbers listed in the recall.
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 Central Monitoring Systems (MFM-CNS and MFM-CNS Lite) because of potential cybersecurity issues identified by the FDA. These software applications manage clinical data for fetal monitoring and maternal vital signs. The recall affects specific units with listed serial numbers.
The recall is due to potential cybersecurity issues identified by the FDA through an It Has Come To Our Attention Letter (IHCTOA). The exact nature of the cybersecurity risk is not specified in the recall notice, so the specific danger mechanism cannot be clearly described.
Healthcare providers using the Central Monitoring Systems for fetal monitoring and maternal care are likely affected. The risk is primarily for medical facilities that have the specific model numbers and serial numbers listed in the recall.
Check if your Central Monitoring System has the model numbers MFM-CNS or MFM-CNS Lite and the specific serial numbers listed in the recall notice. The recall includes units with UDI-DI codes starting with 06944413800236 or 06944413807983.
Verify if your Central Monitoring System has the model numbers MFM-CNS or MFM-CNS Lite and the specific serial numbers listed in the recall notice.
Edan Diagnostics received an FDA It Has Come To Our Attention Letter regarding potential cybersecurity issues with these devices.
The recall notice states potential cybersecurity issues but does not specify the exact risk or how it could affect users.
Check if your Central Monitoring System has the model numbers MFM-CNS or MFM-CNS Lite and the specific serial numbers listed 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-1151-2026 — Edan Diagnostics Edan Diagnostics Hello, I own a Edan Diagnostics that is covered by recall Z-1151-2026 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.
