Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Central Monitoring System Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA

Recall published 9 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1151-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Edan Diagnostics
Product type
Medical devices
Units affected
395
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: MFM-CNS UDI-DI code: 06944413800236 Serial/Lot Numbers: 460793-M18C12290001 460793-M19109170001 460793-M19200240001 460793-M19411950001 460793-M19804210001 460793-M19912750001 460793-M19B07530001 460793-M20809190001 460793-M20913190002 460793-M20913190001 460793-M20B19040001 460793-M21600070001 460793-M21603510001 460793-M24702870002 460793-M24702870001 460793-M25203640001 460793-M25314460001 460793-M25314460002 460793-M25610650001 460793-M25610650003 460793-M25610650002 EDAN Model: MFM-CNS Lite UDI-DI code: 06944413807983 Serial/Lot Numbers: 460570-M19710380001 460570-M19710370001 460570-M19A06460005 460570-M19A06460006 460570-M19A06460007 460570-M19A06460015 460570-M19A06460008 460570-M19A06460009 460570-M19A06460001 460570-M19A06460011 460570-M19A06460003 460570-M19A06460004 460570-M19A06460010 460570-M19A06460002 460570-M19A06460012 460570-M19A06460013 460570-M19A06460014 460570-M20602690001 460570-M20602690003 460570-M20602690002 460570-M20700020009 460570-M20700020002 460570-M20700020011 460570-M20700020012 460570-M20700020005 460570-M20700020007 460570-M20700020013 460570-M20700020008 460570-M20700020003 460570-M20700020004 460570-M20700020001 460570-M20700020010 460570-M20700020006 460570-M20807880003 460570-M20807880005 460570-M20807880001 460570-M20807880002 460570-M20807880004 460570-M20A08380001 460570-M20A08380004 460570-M20A08380005 460570-M20A08380002 460570-M20A08380003 460570-M20C16310008 460570-M20C16310009 460570-M20C16310010 460570-M20C16310004 460570-M20C16310006 460570-M20C16310001 460570-M20C16310002 460570-M20C16310003 460570-M20C16310005 460570-M20C16310007 460570-M24814460001 460570-M24814460002 460570-M24814460004 460570-M24814460003 460570-M24814460005 460570-M24B06920003 460570-M24B06920001 460570-M24B06920004 460570-M24B06920002 460570-M24B06920005 460570-M25216230002 460570-M25216230004 460570-M25216230005 460570-M25216230001 460570-M25216230006 460570-M25407560001 460570-M25407560002 460570-M25511390003 460570-M25511390001 460570-M25511390004 460570-M25511390002 461334-M25321000004 461334-M25321000008 461334-M25321000014 461334-M25321000019 461334-M25321000022 461334-M25321000034 461334-M25321000039 461334-M25321000055 461334-M25321000068 461334-M25321000070 461334-M25321000077 461334-M25321000090 461334-M25321000097 461335-M25320990002 461335-M25320990026 461335-M25320990051 461335-M25320990062 461335-M25320990068 461335-M25320990070 461335-M25320990074 461335-M25320990077 461335-M25320990086 461335-M25320990090 461335-M25320990092 461335-M25320990098 461335-M25320990108 461335-M25320990121 461335-M25320990132 461335-M25320990136 461335-M25320990138 461335-M25320990139 461335-M25320990152 461335-M25320990156 461335-M25320990157 461335-M25320990159 461335-M25320990181 461334-M25321000015 461334-M25321000029 461334-M25321000035 461334-M25321000044 461334-M25321000049 461334-M25321000053 461334-M25321000056 461334-M25321000060 461334-M25321000067 461334-M25321000075 461334-M25321000083 461334-M25321000087 461334-M25321000098 461335-M25320990003 461334-M25321000007 461334-M25321000010 461334-M25321000017 461334-M25321000024 461334-M25321000028 461334-M25321000030 461334-M25321000037 461335-M25320990007 461335-M25320990009 461335-M25320990011 461335-M25320990034 461335-M25320990037 461335-M25320990039 461335-M25320990041 461334-M25321000048 461334-M25321000051 461334-M25321000052 461334-M25321000063 461334-M25321000066 461334-M25321000074 461334-M25321000078 461335-M25320990050 461335-M25320990054 461335-M25320990058 461335-M25320990063 461335-M25320990065 461335-M25320990069 461335-M25320990076 461334-M25321000080 461334-M25321000094 461334-M25321000099 461334-M25321000100 461335-M25320990004 461335-M25320990008 461335-M25320990030 461335-M25320990093 461335-M25320990095 461335-M25320990099 461335-M25320990117 461335-M25320990123 461335-M25320990147 461335-M25320990160 461335-M25320990171 461335-M25320990175 461335-M25320990183 461335-M25320990190 461335-M25320990032 461335-M2532099003…
UPC codes
06944413800236, 06944413807983

Products covered by this recall

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 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. Component: No

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 06944413800236
  • 06944413807983

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 460793-M18C12290001 460793-M19109170001 460793-M19200240001 4607
  • 460570-M19710380001 460570-M19710370001 460570-M19A06460005 4605

Model or item number

On the rating label, the box or the instruction sheet.

  • MFM-CNS

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Edan Diagnostics — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Edan Diagnostics — 9833 Pacific Heights Blvd, San Diego, CA, 92121-4707

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Edan Diagnostics medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 06944413800236, 06944413807983; lot code 460793-M18C12290001 460793-M19109170001 460793-M19200240001 4607, 460570-M19710380001 460570-M19710370001 460570-M19A06460005 4605; model number MFM-CNS. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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