Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Patient Monitor 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-1149-2026
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
379
Distribution
Nationwide
Made in
United States
Lot / code info
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-M2…
UPC codes
06944413815889, 06944413815896

Products covered by this recall

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

Check your product

The notice names 6 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.

  • 06944413815889
  • 06944413815896

Lot or batch code

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

  • 262541-M24816120001 262541-M24A09820001 262541-M24B06240003 2625
  • 262542-M23808800001 262542-M24B06270001 262542-M24B06280001 2625

Model or item number

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

  • iX10
  • iX12

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. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

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 06944413815889, 06944413815896; lot code 262541-M24816120001 262541-M24A09820001 262541-M24B06240003 2625, 262542-M23808800001 262542-M24B06270001 262542-M24B06280001 2625; model number iX10, iX12. 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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