Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NameCentral
- Monitoring System Model/Catalog NumberMFM-CNS
- MFM-CNS Lite Product DescriptionThe 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 additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware
- ComponentNo
- Lot codes and dates
- EDAN ModelMFM-CNS
- UDI-DI code06944413800236
- Serial/Lot Numbers
460793-M18C12290001460793-M19109170001460793-M19200240001460793-M19411950001460793-M19804210001460793-M19912750001460793-M19B07530001460793-M20809190001460793-M20913190002460793-M20913190001460793-M20B19040001460793-M21600070001460793-M21603510001460793-M24702870002460793-M24702870001460793-M25203640001460793-M25314460001460793-M25314460002460793-M25610650001460793-M25610650003460793-M25610650002
- EDAN ModelMFM-CNS
- Lite UDI-DI code06944413807983
- Serial/Lot Numbers
374 of 374 codes
460570-M19710380001460570-M19710370001460570-M19A06460005460570-M19A06460006460570-M19A06460007460570-M19A06460015460570-M19A06460008460570-M19A06460009460570-M19A06460001460570-M19A06460011460570-M19A06460003460570-M19A06460004460570-M19A06460010460570-M19A06460002460570-M19A06460012460570-M19A06460013460570-M19A06460014460570-M20602690001460570-M20602690003460570-M20602690002460570-M20700020009460570-M20700020002460570-M20700020011460570-M20700020012460570-M20700020005460570-M20700020007460570-M20700020013460570-M20700020008460570-M20700020003460570-M20700020004460570-M20700020001460570-M20700020010460570-M20700020006460570-M20807880003460570-M20807880005460570-M20807880001460570-M20807880002460570-M20807880004460570-M20A08380001460570-M20A08380004460570-M20A08380005460570-M20A08380002460570-M20A08380003460570-M20C16310008460570-M20C16310009460570-M20C16310010460570-M20C16310004460570-M20C16310006460570-M20C16310001460570-M20C16310002460570-M20C16310003460570-M20C16310005460570-M20C16310007460570-M24814460001460570-M24814460002460570-M24814460004460570-M24814460003460570-M24814460005460570-M24B06920003460570-M24B06920001
- Amount recalled
- 395
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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