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RecallWatchMedical Device Safety
Class IIOngoingZ-1151-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS

Edan DiagnosticsSan Diego, CA, United StatesReported Jan 28, 2026 · 5 months ago
Legal News Analyst ·

Reason for 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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeModel MFM-CNS
    396 affected lots
    460793-M18C12290001460793-M19109170001460793-M19200240001460793-M19411950001460793-M19804210001460793-M19912750001460793-M19B07530001460793-M20809190001
    +388 more460793-M20913190002460793-M20913190001460793-M20B19040001460793-M21600070001460793-M21603510001460793-M24702870002460793-M24702870001460793-M25203640001460793-M25314460001460793-M25314460002460793-M25610650001460793-M25610650003460793-M2561065000206944413807983460570-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-M24B06920001460570-M24B06920004460570-M24B06920002460570-M24B06920005460570-M25216230002460570-M25216230004460570-M25216230005460570-M25216230001460570-M25216230006460570-M25407560001460570-M25407560002460570-M25511390003460570-M25511390001460570-M25511390004460570-M25511390002461334-M25321000004461334-M25321000008461334-M25321000014461334-M25321000019461334-M25321000022461334-M25321000034461334-M25321000039461334-M25321000055461334-M25321000068461334-M25321000070461334-M25321000077461334-M25321000090461334-M25321000097461335-M25320990002461335-M25320990026461335-M25320990051461335-M25320990062461335-M25320990068461335-M25320990070461335-M25320990074461335-M25320990077461335-M25320990086461335-M25320990090461335-M25320990092461335-M25320990098461335-M25320990108461335-M25320990121461335-M25320990132461335-M25320990136461335-M25320990138461335-M25320990139461335-M25320990152461335-M25320990156461335-M25320990157461335-M25320990159461335-M25320990181461334-M25321000015461334-M25321000029461334-M25321000035461334-M25321000044461334-M25321000049461334-M25321000053461334-M25321000056461334-M25321000060461334-M25321000067461334-M25321000075461334-M25321000083461334-M25321000087461334-M25321000098461335-M25320990003461334-M25321000007461334-M25321000010461334-M25321000017461334-M25321000024461334-M25321000028461334-M25321000030461334-M25321000037461335-M25320990007461335-M25320990009461335-M25320990011461335-M25320990034461335-M25320990037461335-M25320990039461335-M25320990041461334-M25321000048461334-M25321000051461334-M25321000052461334-M25321000063461334-M25321000066461334-M25321000074461334-M25321000078461335-M25320990050461335-M25320990054461335-M25320990058461335-M25320990063461335-M25320990065461335-M25320990069461335-M25320990076461334-M25321000080461334-M25321000094461334-M25321000099461334-M25321000100461335-M25320990004461335-M25320990008461335-M25320990030461335-M25320990093461335-M25320990095461335-M25320990099461335-M25320990117461335-M25320990123461335-M25320990147461335-M25320990160461335-M25320990171461335-M25320990175461335-M25320990183461335-M25320990190461335-M25320990032461335-M25320990038461335-M25320990052461335-M25320990066461335-M25320990081461335-M25320990096461335-M25320990113461335-M25320990114461335-M25320990124461335-M25320990143461335-M25320990144461335-M25320990158461335-M25320990161461335-M25320990165461335-M25320990187461335-M25320990191461335-M25320990195461334-M25321000005461334-M25321000018461334-M25321000038461334-M25321000050461334-M25321000057461334-M25321000065461334-M25321000081461334-M25321000082461334-M25321000086461334-M25321000095461335-M25320990001461335-M25320990016461335-M25320990023461335-M25320990025461335-M25320990031461335-M25320990046461335-M25320990060461335-M25320990064461335-M25320990067461335-M25320990073461335-M25320990075461335-M25320990079461335-M25320990094461335-M25320990097461335-M25320990102461335-M25320990106461335-M25320990107461335-M25320990109461335-M25320990111461335-M25320990115461335-M25320990120461335-M25320990125461335-M25320990137461335-M25320990141461335-M25320990145461335-M25320990170461335-M25320990184461334-M25321000002461334-M25321000011461334-M25321000012461334-M25321000031461334-M25321000032461334-M25321000040461334-M25321000047461334-M25321000084461334-M25321000088461335-M25320990005461335-M25320990021461335-M25320990033461335-M25320990035461334-M25321000001461334-M25321000003461334-M25321000006461334-M25321000013461334-M25321000016461334-M25321000025461334-M25321000033461334-M25321000036461334-M25321000045461334-M25321000061461334-M25321000062461334-M253210000794613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What the firm is doing

On 10/24/2025, the firm emailed notifying customers of a product recall. On 11/06/2025, the firm emailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them of labeling issues involving cybersecurity which arose from a communication from the U.S. Food & Drug Administration. -First issue involves an inappropriate publicly routable IP address that was used as an example in the user manual for demonstrating user-configurable IP settings and Second issue involves an inappropriate publicly IP address that was used as the factory default configuration. Customer are instructed to: 1. Immediately examine their inventory and quarantine product subject to correction. 2. If customers may have further distributed affected product, identify their customers and notify them at once of this product correction. The notification to their customers may be enhanced by including the enclosed URGENT MEDICAL DEVICE CORRECTION. 3. For affected product still in their inventory, place copy of the enclosed Notice Before Use and Corrigenda of User Manual into its package before distribution. 4. For affected product that has been distributed or is in use: (1) Confirm that they have received and acknowledged Corrigenda of User Manual. Print out a copy, attach to the User Manual. (2) Confirm the publicly routable IP address 202.114.4.* is NOT used in the User Maintain in the device. If 202.114.4.* is being used, change to appropriate IP settings of device in the Network Setup according to Instruction Instructions for IP Settings Configuration. 5. Complete the attached Acknowledgement and Receipt Form, sign it, and return a scanned copy to the sender of this notification by email. For questions - Contact: EDAN Instruments, Inc. Monday to Friday 09:00-17:00 (UTC+8) Tel:+86-0755-26898326 EDAN Diagnostics, Inc. Monday to Friday 09:00-17:00 (PST) Tel: 1-(858)-750-3066

DistributionShow details

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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