FDAOctober 24, 2025device
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
edan diagnosticsedan
UPCs
0694441380023606944413807983
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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