What are the risks associated with the EDAN patient monitor recall?

The recall is due to potential cybersecurity vulnerabilities that could impact patient safety and data security. Users should discontinue use immediately.

How do I check if my EDAN monitor is affected by the recall?

Check the model numbers and serial numbers listed on the recall notice. If your device matches any of these, it is affected.

What should I do if I have an affected EDAN monitor?

Stop using the monitor immediately and follow the recall instructions from EDAN. Contact them for further guidance.

Is there compensation for returning the recalled monitors?

Yes, patients and healthcare providers are advised to follow the return instructions provided by EDAN for potential refunds or replacements.

Where can I find more information about the recall?

You can visit the FDA's website or EDAN's official website for detailed information on the recall and safety instructions.

What is the classification of the EDAN patient monitor recall?

The recall is classified as Class II, indicating that the device may cause temporary or medically reversible health consequences.

How long does it take to process a refund for the recalled monitors?

The timeline for processing refunds or replacements can vary, but it typically takes 4-6 weeks.

What are the identifiers for the recalled EDAN monitors?

The affected models include iX10, iX12, and iX15, with specific serial numbers listed in the recall announcement.

Can I still use my EDAN monitor if it seems fine?

It is advised to stop using the monitor regardless of its current functionality due to potential cybersecurity risks.

What steps should I document during the recall process?

Keep records of your communications with EDAN, including dates, times, and details of your correspondence, as well as any receipts or documentation related to the monitor.

HIGHOctober 24, 2025

EDAN Patient Monitors Recalled Due to Cybersecurity Risks

EDAN recalled 379 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models iX10, iX12, and iX15 pose risks to patient safety. Healthcare providers should stop using these devices immediately.

Quick Facts at a Glance

Recall Date: October 24, 2025
Hazard Level: HIGH
Brand: Edan Diagnostics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled models include EDAN Patient Monitor iX10, iX12, and iX15. These monitors can display, analyze, and control physiological measurements. They were distributed worldwide, including states in the U.S. and Mexico.

The Hazard

The recall stems from a letter received from the FDA regarding potential cybersecurity vulnerabilities that could compromise patient data and device functionality. These issues could lead to incorrect monitoring of vital signs.

Reported Incidents

No specific incidents of harm have been reported related to the recalled monitors. However, the potential for cybersecurity breaches represents a significant risk.

What to Do

Stop using the affected devices immediately. Follow the recall instructions provided by EDAN Diagnostics. Contact them or your healthcare provider for further instructions.

Contact Information

For more details, call EDAN Diagnostics at 1-800-XXX-XXXX or visit their website at www.edandiagnostics.com.

Key Facts

379 units recalled
Models: iX10, iX12, iX15
Stop use immediately
Contact manufacturer for instructions
FDA involvement due to cybersecurity risks

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypePatient Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: iX10 UDI-DI code: 06944413815889 Serial/Lot Numbers: 262541-M24816120001 262541-M24A09820001 262541-M24B06240003 262541-M24B06240002 262541-M24B06240001 262541-M25110410016 262541-M25110420014 262541-M25110420008 262541-M25110420009 262541-M25110420024 262541-M25110420023 262541-M25110420025 262541-M25110420018 262541-M25110410001 262541-M25110410009 262541-M25110410003 262541-M25110410004 262541-M25110410011 262541-M25110410015 262541-M25110410020 262541-M25110410002 262541-M25110410012 262541-M25110410005 262541-M25110410013 262541-M25110410014 262541-M25110410007 262541-M25110410008 262541-M25110410017 262541-M25110410018 262541-M25110410019 262541-M25110410010 262541-M25110420011 262541-M25110410006 262541-M25110420007 262541-M25110420020 262541-M25110420013 262541-M25110420001 262541-M25110420019 262541-M25110420022 262541-M25110420003 262541-M25110420010 262541-M25110420015 262541-M25110420004 262541-M25110420016 262541-M25110420012 262541-M25110420005 262541-M25110420017 262541-M25110420021 262541-M25110420006 262541-M25110420002 269944-M25514090006 269944-M25514090002 269944-M25514090004 269944-M25514090008 269944-M25514090007 269944-M25514090001 269965-M25510270004 269965-M25510270003 269965-M25510270001 269944-M25514090009 269944-M25514090005 269944-M25514090010 269965-M25510270002 269965-M25510270005 269944-M25514090003 262541-M25514080006 262541-M25510240004 262541-M25510240010 262541-M25514080005 262541-M25514080004 262541-M25514080002 262541-M25514080013 262541-M25514080003 262541-M25510240012 262541-M25510240001 262541-M25510240008 262541-M25510240015 262541-M25510240006 262541-M25510240009 262541-M25514080008 262541-M25510240011 262541-M25514080012 262541-M25510240007 262541-M25510240002 262541-M25510240003 262541-M25514080009 262541-M25510240005 262541-M25514080011 262541-M25514080007 262541-M25514080001 262541-M25510240013 262541-M25510240014 262541-M25514080010 262541-M25510240016 262541-M25704070016 262541-M25704070008 262541-M25704060002 262541-M25704060013 262541-M25704070011 262541-M25704070010 262541-M25704070003 262541-M25704070002 262541-M25704070009 262541-M25704070007 262541-M25704070005 262541-M25704070001 262541-M25704060018 262541-M25704060024 262541-M25704060014 262541-M25704070020 262541-M25704070018 262541-M25704070023 262541-M25704070022 262541-M25704070021 262541-M25704070019 262541-M25704070013 262541-M25704070006 262541-M25704070004 262541-M25704070012 262541-M25704060006 262541-M25704060005 262541-M25704060010 262541-M25704060020 262541-M25704060023 262541-M25704060021 262541-M25704060009 262541-M25704070015 262541-M25704070017 262541-M25704070025 262541-M25704060004 262541-M25704060008 262541-M25704060012 262541-M25704060016 262541-M25704060022 262541-M25704060001 262541-M25704060007 262541-M25704060011 262541-M25704060017 262541-M25704060019 262541-M25704070014 262541-M25704070024 262541-M25704060003 262541-M25704060015 262541-M25704060025 EDAN Model: iX12 UDI-DI code: 06944413815896 Serial/Lot Numbers: 262542-M23808800001 262542-M24B06270001 262542-M24B06280001 262542-M24B06250001 262542-M24B06280002 262542-M24B06270002 262542-M24B06260001 262542-M24B06250002 262542-M25110440008 262542-M25110430024 262542-M25110430020 262542-M25110430009 262542-M25110430006 262542-M25110430001 262542-M25110440016 262542-M25110440010 262542-M25110440005 262542-M25110440003 262542-M25110440001 262542-M25110430021 262542-M25110430013 262542-M25110430007 262542-M25110440011 262542-M25110430003 262542-M25110440017 262542-M25110440015 262542-M25110440020 262542-M25110430005 262542-M25110430010 262542-M25110430012 262542-M25110430014 262542-M25110430018 262542-M25110440007 262542-M25110430011 262542-M25110430016 262542-M25110430017 262542-M25110440013 262542-M25110440018 262542-M25110430019 262542-M25110440019 262542-M25110440014 262542-M25110440006 262542-M25110430023 262542-M25110430015 262542-M25110430002 262542-M25110430022 262542-M25110440012 262542-M25110430004 262542-M25110440009 262542-M25110440004 262542-M25110440002 262542-M25110430025 262542-M25110430008 269943-M25514100009 269943-M25514100033 269963-M25510300013 269943-M25514100030 269943-M25514100031 269963-M25510300011 269963-M25510300026 269963-M25510300008 269943-M25514100040 269943-M25514100027 269943-M25514100005 269963-M25510300030 269963-M25510300005 269943-M25514100015 269963-M25510300029 269943-M25514100032 269943-M25514100037 269963-M25510300025 269963-M25510300028 269943-M25514100038 269963-M25510300012 269943-M25514100039 269943-M25514100034 269943-M25514100028 269963-M25510300003 269963-M25510300010 269963-M25510300014 269943-M25514100026 269963-M25510300002 269943-M25514100021 269943-M25514100001 269963-M25510300018 269943-M25514100003 269963-M25510300021 269963-M25510300016 269963-M25510300009 269943-M25514100020 269963-M25510300019 269943-M25514100012 269963-M25510300004 269943-M25514100035 269943-M25514100014 269963-M25510300017 269963-M25510300001 269963-M25510300023 269963-M25510300022 269963-M25510300007 269943-M25514100019 269943-M25514100007 269943-M25514100025 269943-M25514100013 269963-M25510300027 269963-M25510300015 269963-M25510300006 269943-M25514100029 269943-M25514100024 269943-M25514100022 269943-M25514100017 269943-M25514100004 269943-M25514100002 269943-M25514100008 269943-M25514100018 269943-M25514100006 269943-M25514100010 269943-M25514100011 269963-M25510300024 269963-M25510300020 269943-M25514100036 269943-M25514100023 269943-M25514100016 262542-M25510290001 262542-M25510280012 262542-M25510280015 262542-M25510280010 262542-M25510280011 262542-M25510290012 262542-M25510290005 262542-M25510290003 262542-M25510290002 262542-M25510280007 262542-M25510280005 262542-M25510290007 262542-M25510290006 262542-M25510280016 262542-M25510280004 262542-M25510280003 262542-M25510290011 262542-M25510290009 262542-M25510290010 262542-M25510280001 262542-M25510280002 262542-M25510280008 262542-M25510280009 262542-M25510280014 262542-M25510290013 262542-M25510280006 262542-M25510290008 262542-M25510290004 262542-M25510280013 262542-M25704090002 262542-M25704090015 262542-M25704090017 262542-M25704090004 262542-M25704090009 262542-M25704090024 262542-M25704090021 262542-M25704090014 262542-M25704090025 262542-M25704090007 262542-M25704090008 262542-M25704090003 262542-M25704090001 262542-M25704090019 262542-M25704090023 262542-M25704090011 262542-M25704090020 262542-M25704090010 262542-M25704090005 262542-M25704080020 262542-M25704090022 262542-M25704090012 262542-M25704090013 262542-M25704090016 262542-M25704090006 262542-M25704080009 262542-M25704080016 262542-M25704080018 262542-M25704080022 262542-M25704080008 262542-M25704080010 262542-M25704090018 262542-M25704080014 262542-M25704080012 262542-M25704080002 262542-M25704080015 262542-M25704080017 262542-M25704080023 262542-M25704080005 262542-M25704080004 262542-M25704080007 262542-M25704080021 262542-M25704080006 262542-M25704080001 262542-M25704080011 262542-M25704080024 262542-M25704080003 262542-M25704080025 262542-M25704080019 262542-M25704080013 EDAN Model: iX15 UDI-DI code: 06944413815902 Serial/Lot Numbers: 262543-M24B06290002 262543-M24B06290001 262543-M25110450003 262543-M25110450002 262543-M25110450001 262543-M25110450004 262543-M25110450005 262543-M25303610001 269961-M25510320004 269961-M25510320002 269961-M25510320010 269942-M25514110006 269961-M25510320008 269961-M25510320005 269961-M25510320011 269942-M25514110001 269942-M25514110003 269961-M25510320012 269961-M25510320013 269942-M25514110010 269961-M25510320009 269961-M25510320006 269961-M25510320001 269942-M25514110007 269942-M25514110008 269961-M25510320015 269961-M25510320003 269942-M25514110005 269961-M25510320014 269961-M25510320007 269942-M25514110004 269942-M25514110002 269942-M25514110009

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

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