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U.S. Department of Health and Human Services

Class 2 Device Recall EDAN

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 Class 2 Device Recall EDANsee related information
Date Initiated by FirmOctober 24, 2025
Date PostedJanuary 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1150-2026
Recall Event ID 97879
510(K)NumberK120727 K232694 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductBrand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No
Code Information EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C04930005 261432-M20C04930004 261432-M20C04930003 261432-M20C04930006 261432-M21111490005 261432-M21111490004 261432-M21111490003 261432-M21111490002 261432-M21111490006 261432-M21111490001 261432-M21206490002 261432-M21206490006 261432-M21206490001 261432-M21206490005 261432-M21206490004 261432-M21206490003 261432-M21409870005 261432-M21409870003 261432-M21409870004 261432-M21409870001 261432-M21409870002 261432-M21409870006 261432-M21509140001 261432-M21509140003 261432-M21509140005 261432-M21509140004 261432-M21509140006 261432-M21509140002 261432-M21706970007 261432-M21706970008 261432-M21706970005 261432-M21706970001 261432-M21706970004 261432-M21706970006 261432-M21809930002 261432-M21909020003 261432-M21909020004 261432-M21909020002 261432-M21810820020 261432-M21810820006 261432-M21810820003 261432-M21809930005 261432-M21809930004 261432-M21809930003 261432-M21809930001 261432-M21909020001 261432-M18400410002 261432-M18310890001 261432-M18501600001 261432-M18802330001 261432-M19912390001 261432-M20412240001 261432-M20708340007 261432-M20915430001 261432-M20B09110001 261432-M20B13840001 261432-M20C10170001 261432-M21204410002 261432-M21204410003 261432-M21204410004 261432-M21204410001 261432-M21306400002 261432-M21306400003 261432-M21306400001 261432-M21316340001 261432-M21404840001 261432-M21512920002 261432-M21512920001 261432-M21615470001 261432-M21702760001 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 EDAN Model: MFM-CMS UDI-DI code: 06944413814264 Serial/Lot Numbers: 262237-M24611330012 262237-M24611330001 262237-M24611330011 262237-M24611330014 262237-M24611330009 262237-M24611330019 262237-M24611330004 262237-M24611330008 262237-M24611330007 262237-M24611330017 262237-M24611330010 262237-M24611330003 262237-M24611330005 262237-M24611330015 262237-M24611330013 262237-M24611330018 262237-M24611330002 262237-M24611330006 262237-M24611330016 262237-M24814380001 262237-M24905030001 262237-M24C17400001 262237-M24C17400003 262237-M24C17400004 262237-M24C17400002 262237-M24C17400005 MRM-CMSIII 262237-M24B06940008 262237-M24B06940001 262237-M24B06940003 262237-M24B06940005 262237-M24B06940010 262237-M24B06940004 262237-M24B06940007 262237-M24B06940006 262237-M24B06940002 262237-M24B06940009
FEI Number 3009499478
Recalling Firm/
Manufacturer		 Edan Diagnostics
9833 Pacific Heights Blvd
San Diego CA 92121-4707
For Additional Information ContactChao Lin
858-7503066
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce195
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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